AN AYURVEDIC COMPOUND INTHIRD MOLAR SURGERY
-A DOUBLE BLIND TRIAL
Dr.
Varghese Mani, BSc MDS,
Asst. Prof, of Ora! Surgery &
Dr. C. Basker Rao, MDS, Prof, of Oral Surgery, Kastbrba Medical College,
Manipal, Karnataka.
Paper at 1st International & 34th
National Dental Conference at Bombay 20-24 Jan 1980
Ayurveda
is the indigenous health science which has been nursed and nurtured by the reputed
Rishi's of ancient India. Recently Ayurveda has been rejuvenated by research
studies and a good number of drugs are being introduced. The aim of this study
was to investigate the anti-inflammatory property of an Ayurvedic drug called
'R.Compound' which has aroused considerable curiosity in the recent past.
An
abnormally placed tooth can result in a good number of untoward pathologies.
These usually necessitate prophylactic or curative removal of the impacted
teeth. As mandibular third molars are the most common impacted teeth, the
removal of the same is a routine minor surgical procedure in the field of oral
surgery. Pain, swelling and trismus are the common post-operative complications
after the procedure which is an embarrassment for the surgeon as well as the
patient. Numerous enthusiastic studies and trials using physical methods plant
and animal enzymes, steroids and non-steroid pharmaceutical agents have been
carried out in search of a solution with varying degrees of success.
In
this instance R,Compound an Ayurvedic drug has been subjected to a double blind
trial on patients undergoing surgical removal of impacted mandibular third
molars to ascertain whether it has got any bearing on the postoperative
complications like pain, swelling and trismus.
Material
and Methods:
The clinical material consisted of 80 patients undergoing surgical removal of
impacted mandibular third molars.
i)
The depth, position and situation of the impacted third molar was evaluated
clinically andradiologically and an attempt was made to keep them as
far as possible as having same anatomical status. The general medical condition
of the patient was also evaluated and the selected patients were healthy
without any systemic ailments.
Patients
were divided into two groups, 40 patients received R.Compound, the rest 40 received
the placebo.
The dosage
was two capsules three times a day for 5 days, starting 24 hours prior to
surgery. The other group received similar looking placebo capsules in the same
dosage. As an analgesic, paracetamol 500 mgs tablets were used. Patients were
instructed to take the same as and when it was required.
Surgical techniques:
Standard set
of instruments used forthe third molar surgery in the department of oral
surgery was used.
Flap technique
On all
occasions Flap technique was used for the removal of the surrounding bone.
After the delivery of the tooth from the socket, proper debridement and toilet
of the socket was done. The flaps were approximated and closed by two or three interrupted
sutures. A pressure pack was given intra-orally. All the surgical procedures
were done by the same operator.
All the
patients were evaluated on 1st, 2nd, 3rd, 5th and 7th post-operative days.
Objective assessments were made for swelling and trismus. Pain being a subjective
symptom was assessed according to the number of analgesic tablets consumed
each day.
Swelling
Assessment of the oedema was done by measuring the
thickness of the cheek and alveolus together, pre and post-operatingly. Two
points were taken for the measurements. The lingual aspects of the distolingual
cusp of the second molar at the occlusal level was taken as the intra-oral
point. A line was drawn from the angle of mandible to the corner of the mouth
and a point was marked 3.5 cm from the angle of the jaw. This point was taken
as the extra oral one. The distance between two points has been taken, as the
thickness of the cheek and alveolus. This measurement was done with the
minimal opening of the mouth.
Trismus
With the help of a Boley'sguage the distance between
the incisal edge of the maxillary and mandibular central incisors was measured
when the mouth was fully opened.
Pain
All the recorded measurements were tabulated and
subjected to statistical evaluation.
Results:
1. Swelling was less (highly significant) on all
post-operative days in the R.Compound group.
Only 12.5% in the placebo group had complete relief of swelling on the 7th postoperative
day.
On the other hand 92.5% in the R.Compound group had complete relief.
2. Trismus was significantly less in the R.Compound group, during the 1 st 5 post-operative days. Against 87.5% in the R.Compound group only 7.5% in placebo group experienced complete relief of trismus on 7th postoperative day.
Regarding the consumption of analgesic tablet, this
R.Compound group needed less number of analgesic tablets, this being highly
significant upto the 5thpost-operative day.
Discussion:
R.Compound has recently been tried in the field of
orthopaedics with noteworthy success. This has already resulted in a couple of
studies in dentistry also with favourable results. The exact mode of action of
this drug is unknown. It is supposed to be general metabolic stimulant and
activates the cells of reticulo-endothelial system. It is claimed to be
beneficial to arrest degenerative process and to build up body resistance.
The present double-blind trial was undertaken to
evaluate the effects of R. Compound in a more objective manner in the
management of post-operative swelling, trismus and pain. This study has
demonstrated that the use of R. compound has a significant favorable effect, on
the course of all three post-operative complications like swelling, trismus
and pain.
The drug was well tolerated by the patients and no
side effects were noticed. Still, clinical and pharmacological studies are
essential to standardize the dose and to find out the active principles,
bio-transformation and mode of action of the drug.
Though it was not intended to investigate the
inter-relationship of these complications in the present study it could be said
that the trismus and swelling were more related than trismus and pain. This
observation is in accordance with the study conducted by Tin Bosch and Van Gool
in 1977. But Lucian (1965) is of the opinion that post-operative pain and
trismus were closely related.
It can be
concluded that :-
1. R.
Compound is effective in alleviation of post-operative complications.
2. It
is remarkably free from side-effects.
3. R.
Compound is cheap in comparison with other anti-inflammatory drugs.