IN ACUTE TRAUMATIC CONDITIONS IN DENTISTRY

APART FROM ANTI INFLAMMATORY , ANALGESIC & ANTIPYRETIC PROPERTIES

R. COMPOUND BEHAVES LIKE ANTIEDEMATOUS TOOL

 

A CONTROLLED CLINICAL STUDY WITH R.COMPOUND

By

Dr. M. BALAKOTI REDDY, MDS

Assistant Professor, Dept. of Oral Surgery & Maxillo – Facial Surgery,

Dr. K.S. BHAT. MDS

Director of Dental Studies, Department odf Oral Surgery & Maxillo – Facial Surgery

Dr. CH. BHASKER RAO, MDS

Associate Professor, Department of Oral Surgery & Maxillo – Facial Surgery,

College of Dental Surgery, Manipal – 576 119

 

INTRODUCTION

 

Surgeons from ancient day have found it necessary to improve upon their methods, medication, techniques and instrumentation to overcome their problems, to make surgery easy for the patients. The traumatic swellings and their complexities continue to disturb the surgeons in general and the oral surgeons in particular. Acute trauma and its consequences following removal of the impacted 3rd molars is of very common occurrence.

Numerous anti-inflammatory drugs ranging from basic aspirin, through the Phenylbutazone group, Indomethacine, Ibuprofen etc, are being used with varying degrees of successful therapeutic values but have their corresponding side effects. Because of the variable results obtainable with these drugs, investigators con­tinue to seek more and more effective methods of treatment for the management of traumatic swellings. R. compound, an ayurvedic drug, is claimed to possess significant anti-inflammat­ory and analgesic properties. '4 The reported freedom from toxic effects even on prolonged use was a strong consideration to take up this drug for a fair clinical trial, the results of which are being presented here.

In the present study, R. Compound was sub­mitted to a clinical trial with a random sample of 60 patients undergoing surgical removal of im­pacted mandibular third molars to evaluate the efficacy of the drug in the control of post-opera­tive complications, with particular reference to trismus, swelling and pain.

 

COMPOSITION OF "R. COMPOUND"

R. Compound is an indigenous drug man­ufactured by Messrs. Alarsin Pharmaceuticals, Bombay, containing the following ingredients:

Mafiayograj Guggul with Gold Bhasma: 200 Mg.

Maharasnadi Quath: 67 mg.

 

1. Guggul:

English:- Indian Bedellium - Salai Tree Kannada-Guggula

Tamil - Gukkulu; Maisatchi Kunjiliyam Telugu - Maisakshi Guggulu

Latin - Balasmodendrom Mukul

It is an Oleo resin containing volatile oil, gum resin and a bitter principle. It is excerted through the skin, mucous membrane and kid­neys and during the course of its excretion, exerts an anti-inflammatory action. Ramachandra observed that R. Compound has got anti-suppurative properties 12

 

2. Maharasnadi quath is prepared by proces­sing twenty five different herbal drugs. Its chief ingredient is "Rasna".

English - Alpinea chinensis

Kannada - Maharasnadivadi

Tamil - Chittrattai

Telugu - Sanna rashtram

Rasna has antirheumatic, analgesic, anti-in­flammatory and antipyretic actions. It is ex­creted through skin and kidneys.

 

Gold, which is a constituent of R. Compound is a drug which has been reputed for its anti-in­flammatory properties from time immemorial. Unfortunately, gold is highly toxic and fraught with dangers of severe reactions. Many heavy metals like Arsenic, Mercury, Bismuth having such properties, which have been used exten­sively in the past, have been replaced by potent and specific chemo-therapeutic agents.

 

In Ayurveda, which is the ancient system of Indian Medicine, heavy metals are made less toxic by reducing them into an `Ash' form by special processes. This ash is known as `Bhasma' and can be used for prolonged periods without any side reactions, which are usually associated with the use of salts of heavy metals.

 

R. Compound having Gold-Bhasma in small quantities, makes it safe even on prolonged use. Gold in `Ash' form has anti-inflammatory properties. It acts as a "General metabolic stimulant" and activates reticulo endothelial system. It also acts as an antiseptic. ' Today however, these Ayurvedic concepts of dis­eases and treatments yet remain to be explained in terms of modern medical terminol­ogy.

 

REVIEW OF LITERATURE

The review of literature reveals the great di­versity of opinions prevailing in this field. Exter­nal thermal application has been reported to be beneficial in reducing edema and pain by Hen­nessy 4 and Mead . Favourable clinical re­sponse on administration of antihistamines have been observed by Silverman 's and Wohlgenutu'9 . However Lucin 8 , Snyder ", Keesling and Hinds s pointed out that there is no significant effect of antihistamines in reducing post-operative pain, swelling, trismus and haemorrhage. Cortisones have been success­fully employed by Ross et al 13 in acute trauma­tic conditions of the oral cavity. Extensive studies carried out on Oxyphen-butazone and Indomethacine to study the anti-inflammatory effect show that they are effective in controlling post-operative sequlae. However, it has been observed that they are riot completely safe on prolonged use and have side effects.

 

Freedman 3 observed reduction of oedema by using a combination of anti-inflammatory drugs, prednisolone and a water soluble bioflavonoid, in patients undergoing full mouth ex­tractions. However, he pointed out that the danger of spread of infection, delayed repair, adrenal suppression and altered metabolic pro­cess does not advocate the use of these drugs in all cases.

 

Enzymes in different forms have been used for control of post-operative oedema, trismus and pain in oral surgical procedures. Fleuchaus 2 and Shuttee '5 injected hyaluronidase with local anaesthetics, Krause ' administered a combination of enzymes orally, Patrick'°, Pat­rick and Horton " and Tejinder Singh'3 used papase, an extract of a plant carica papaya and Irving Innerfields 5 used streptokinase. The re­sults of all these studies indicate favourable re­sponse.

 

There were no reports in the reviewed litera­ture of the use of R. Compound in dentistry. R. Compound has been tried extensively by or­thopaedic surgeons in India in rheumatoid ar­thritis, osteo-arthritis, synovitis etc., with prom­ising results. 1,12,41 In view of this, the study of clinical application of R. Compound in dentistry seems relevant as these ayurvedic prepara­tions are less expensive, readily available and acceptable to rural population amongst whom ayurveda enjoys a special confidence.

 

MATERIAL AND METHODS

R. Compound was submitted to a clinical trial on patients undergoing surgical re­moval of impacted mandibular third molars. This was done mainly with an aim to ascertain whether R. Compound has got beneficial ef­fects in reducing the post-operative discomfort, trismus, swelling and pain.

 

Sixty patients with impacted mandibular third molars were selected for this study. Patients of both sexes selected at random constituted the sample. Out of this sixty, forty two were males and eighteen were females in the age group of 19 to 42 years. Among this sixty, twenty two were having bilateral impacted third molars. All the cases were evaluated adequately and pa­tients presenting impaction of similar degree were selected, so that trauma inflicted during surgery was approximately the same. All pa­tients selected had no pre-operative symptoms like pain, swelling and trismus. This has permit­ted proper evaluation.

 

These patients were divided into two groups of thirty each in the experimental and control groups. The experimental group received the tablet R. Compound, 2 tablets 3 times a day for 5 days, starting from the day of operation. The control group received none of the anti-inflam­matory drugs. All patients were put on capsule Tetracycline, Resticline 250 mg., six hourly from the day of operation for 5 days.

 

Having observed all the general principles of surgery, the teeth were extracted under local anaesthesia, 2cc of 2% lignocaine hyd­rochloride with adrenaline 1:80.OOO.The surgi­cal technique used for the extraction of the teeth was the bur technique The patients were advised intermittent ice application over the op­erated area for a period of two hours post­operatively. All the patients wer instructed to follow the usual precautions and were advised to report to the department for check-up on the first, second, third, fourth, fifth and seventh post-operative days for clinical evaluation. Post-operative check-up consisted of evaluation of the degree of pain, swelling, trismus and incisal mouth opening. The mouth opening was recorded pre-operatively and on all the post-operative check-up days. Pain and swelling were graded and recorded as nil, mild,moderate, moderately severe and se­vere in degree.

 

In case of bilateral impactions the extrac­tions were done in two sessions so that one side served as experimental and the sub­sequent extraction on the opposite side served as control.

 

 

RESULTS AND DISCUSSION

The present study indicated that R. Com­pound is a potent anti-inflammatory agent with recognizable analgesic effects. As with the other anti-inflammatory agents, the mechanism of action of R. Compound is not known. The effects of R. Compound assessed and expressed in term of scvelling, trismus and pain show the good beneficial effects of this drug on the post-operative features in the group of patients subjected to the study.

 

Swelling: The results of assessment of swelling are given in Table No. 1. The resolu­tion of the oedema is a relative phenomenon de­pending much on the healing powers and resistance of the patient. Qualitatively R. Com­pound behaves like anti-edematous of the anti-inflammatory, anti-pyretic type of drug. Only 40% of the patients treated with R. Com­pound experienced moderate swelling as com­pared to 53% severe and 47% moderately re­vere swelling in the control group on the first post-operative day. A marked difference in the reduction of the swelling was evident on the second post-operative day when 68% of the treated and only 12% of the control groups ex­perienced mild or/no swelling. On the third post­operative day, 87% of the treated and 23°/a of the control groups were relieved of the swelling. On the fifth post-operative day, 98% were re­lieved of swelling in the experimental group against 46% in the control group. Statistical analysis and inference has shown significant difference in the experience of swelling bet­ween the two groups.

 

TABLE-1

Relief from Trismus and Swelling with R. Compound

in terms of % of case observed

Days of assessment

Restoration of Degree of mouth

opening to pre-operative level

 

Expt. Gr.                    Control Gr.

Reduction of Swelling to

Pre-operative level

 

Expt. Gr.                         Control Gr.

1 st day

All experienced

mild to moderate

Trismus

All experienced

moderate to

severe Trismus

40% moderate,

the rest had

mild swelling

53% had severe

47% moderate

swelling.

 

 

2nd day

28

Nil

68

12

3rd day

68

Nil

87

23

4th day

76

22

94

40

5th day

87

36

98

46

7th day

96

66

100

65

 

TRISMUS: Trisums is mainly due to muscu­lar spasm brought about by the painful stimuli. It is very likely as R. Compound seems to posses analgesic qualities, the patients in the treated group experienced less trismus. R. Compound did not prevent the onset of trismus. All the pa­tients experienced inability to open the mouth on the first post-operative day but the degree of trismus was less in the experi­mental group on the second post-operative day, 28% in t4e experimental group could open the mouth against none in the control group. On the third post-operative day 68% in the experimental group could open their mouth normally compared to none in the control group. Trismus was relieved in 87% of the experiment and 36% of the control group by the fifth post-operative day. Trismus persisted only in 4% of the experimen­tal group against 34% in the control group by the seventh post-operative day. This shows that though R. Compound did not prevent the onset of trismus, it is of definite help in the early recovery from it.The difference in the results observed in the two groups was statistically significant.

 

PAIN: All the patinets experienced pain, ranging from 32% mild to 68% moderately se­vere in the experimental group and 13% mod­erately severe to 87% severe in the control group, on the first post operative day. 22% of the experimental group were free of pain on the second post-operative day, compared to none in the control group. The beneficial effects were more evident on the third day. In 48% of the ex­perimental group there was no pain against 11 % in the control group. The pain persisted only in 10% of the experimental group com­pared to 73% in the control group on the fifth post-operative day. On the 7th post operative day there was none in the experimental group against 33% in the control group who com­plained of pain. The difference was statistically significant on all the post operative days. (Table II)

 

TABLE-II

Relief from pain with R. Compound experienced as % of cases observed

Days of assessment

Expt. Group

No pain Mild Moderate Severe

Control Group

No pain   Mild   Moderate  Severe

1 st day

Nil

32

68

Nil

Nil

Nil

13

87

2nd day

22

51

27

Nil

Nil

16

46

38

3rd day

48

43

9

Nil

Nil 11

11

Nil 11

24

40

25

4th day

67

26

7

Nil

14

43

27

16

5th day

90

7

3

Nil

27

49

18

6

7th day

100

Nil

Nil

Nil

67

24

9

Nil

 

The observations in this study in general are similar to the beneficial effects of this drug re­ported by various authors 1,12,14 therby con­firming the efficacy of the drug R. Compound has a definite place in the management of sur­gical cases in dentistry. The well formulated Ayurvedic drugs and preparations are known for their freedom from toxicity and side effects. The majority of the analgesic and anti-inflam­matory drugs available in the market, posses undesirable side-effects like nausea, vomiting and gastric irritation and are potentially toxic

 

CHART N0.1

Showing Complete Relief from Trismus, Swelling and Pain

in the Experimental group and the Control group on 7th Post ­Operative day.

 

 Control Group

                        100%       100%

    Pain

 

agents. As observed in this study, while hav­ing favourable and beneficial effects on the post-operative conditions, no side-effects of any kind were observed with R. Com­pound. Though this is a definite observation, it needs further study specially in comparison with analgesic and anti-inflammatory drugs av­ailable in the modern medicine.

 

SUMMARY AND CONCLUSION

R. Compound has been subjected to a clini­cal trial on 60 patients undergoing surgical re­moval of impacted mandibular third molars. R. Compound, in the present study, was found to be of definite value in the management of post-operative complications like trismus swelling and pain. Though the patients treated with R. Compound experienced ina­bility to open the mouth, the degree of tris­mus was much less and the recovery un­eventful. The drug is of great help in the early resolution of the oedema as evidenced in this study. Even though all patients experi­enced pain, the pain was much less in the ex­perimental group. By the seventh post-opera­tive day, none experienced pain the experimen­tal group against 33% who had pain in the con­trol group.

A conclusion therefore, can be drawn that R. Compound has definite value in the manage­ment of post-operative trismus, oedema and pain. However, further clinical trials are neces­sary to standardise the dosage and duration of therapy. It would be of interest to compare the efficacy of this drug with the commonly used anti-inflammatory drugs. No side effects of any kind that can be attributed to the drug were noticed during the present study.

 

ACKNOWLEDGEMENT

Our thanks are due to Dr. A. Krishna Rao, Dean, Kasturba Medical College, Manipal, for his constant encouragement, help and for al­lowing us to carry out this trial on R. Compound. We are also thankful to Mr. P. G. Shukla of Alar­sin Pharmaceuticals, Bombay for his help and untiring efforts in the smooth completion of the trials and supply of R. Compound.

 

REFERENCE

1. Ethi Rajulu, G.: A clinical study with"R. Compound" -in the treatment of Rheumatoid Arthritis and other chronic Ar­thritis; Paper read at IVth Annual confer­ence of the Association of Orthopaedic Surgeons of A. P. held at Hyderabad on 7th & 8th July, 1972

2. Fleuchaus, P. T.: Effect of hyaluronidase on swelling and trismus after removal of im­pacted mandibularthird molars O.S., O.M., 0. P., 9 : 493, 1956.

3. Freedman Davia: Combination of Pre­dnisolone and vitamin therapy in the control of post-operative oedema. Journal of oral Surgery, Anaesthesia and Hospital O. Surgery, 18 : 332, July, 1960.

4, Hennessy, Thomas: External heat and cold therapy in Oral Surgery. Amer. J. of Or­thodontia and Oral Surg. 27 : 472, Sept., 1941

'nnerfield: Buca1y administered ~'#eotokinase, The New England journal ,. ; Medicine, 258:1069, 1958.

-~      ~~r;:si'irmg & Hinds: Clinical evaluation of an­amines in Oral Surgery using the dou­unknown technque, J.C3. S. 15 : 2?9, Oct., 1957.

% . °;,rause, D.J.: Controlled study on removal d f mandihu6ar third molars. Effen.t of en­zyme mixture on sequeiaw, J.A Cj.A.. 63 : 70, Dec., 1961.

8. Lucian Szmyd: Clinical evaluation of an an­

tihistaminic preparation in Oral Surgery, O.S. O.M. O.P., 9:928, Sept., 1956.

9. Mead,        Sterling:        Hydrotherapy, Amer.J.Ortho and Oral Surg., 25.,: 797, Aug, 1939.

10. Patrick, D. Toto: Clinical evaluation of anti­inflammatory enzyme therapy in inflamma­tion and pain: J. of Dental Medicine, Vol. 1-7,1962.

11. Patrick, S. M. & Horton, R. B.: Plant en­zymes in Oral Surgery, O.S., O.M., O.P., 309, Mar., 1965.

12. Ramchandra, K.: R. Compound in Rheumatoid Arthritis; personal communi­cation; Mediscope, 15 : 6, September, 1972.

13. Ross, et al: Evaluation of hydrocortisone in prevention of post-operative complication after Oral Surgery. J. O. S. 16 : 220, May. 1958.

14. Sardesai, H. V.: Use of R. Compound in Rheumatoid Arthritis; Paper read at 1st congress of South East Asia and Pacific Area League against Rheumatism held at Bombay, 17-21 Feb., 1968.

15. Shuttee: Hyaluronidase in relief of post­operative trismus, swelling and pain, O.S., 0. M., 0. P., 114, Jan., 1962.

16. Silverman, R. E.: Further clinical observa­tions on the use of antihistamines in Oral Surgery; Preliminary report. J. O. S. 12 : 310. 1954.

17. Snyder, B. S.: Effect of antihistamine agents on inflammatory response after sur­gical trauma. J. O. S., Anesthe & Hosp. D. Serr. 18 : 319, July, 1960.

18. Tejinder Singh: Evaluation of papain in the control of post-operative oedern-~. Dissera­tion M.D.S. Oral Surgery, (An t-~~rsity of Bombay, Apr, 1967.

19. Wohigemuth, P.R.: Post-operative oedema in maxillo-facial surgery. American Journal of Surgery, 94: 537, 1957.

 

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