A prospective, double blind, randomized study evaluating the efficacy of systemically administered combination of proteolytic enzymes in third molar surgery: A clinical study.

AIM:

Theaim of the study is to determine the efficacy of systemically administeredcombination of proteolytic enzymes and their timings in third molar surgery.

 OBJECTIVES:

 1. Evaluate efficacy of proteolytic enzymes used as a fixeddose combination in this study in terms of pain and swelling in the immediatepost operative period.

2. Evaluate whether any specific time for example beforesurgery or after surgery of administration of proteolytic enzymes changes theoutcome and post opeartive sequelae.

3. Evaluate whether the outcome also changes whenproteolytic enzymes are used concomitantly with non steroidal anti inflammatorydrugs.

4. Evaluate the quality of life of patients after thirdmolar surgery with and without administration of proteolytic enzymes.

 PATIENTS& METHOD:

 Source of data:-

The patients will be selected from theOPD of the dept. of OMFS, NHDC, Mumbai, whose informed consent will be taken priorto the procedure. A maximum number of200 patients with partially impacted mandibular third molars requiring surgicalextraction will be selected.

  Inclusioncriteria:

1.  Any patient with an partially impactedmandibular third molars (upto Level B,as  per the Pell and Gregory scales)and indicated for its surgical extraction.

2.  Any patient who willingly gives consent forthe being involved in the study

3.  Healthy adult patients in the age group of18-40 years.

Exclusion criteria:

1.    Pregnantfemales and Lactating mothers.

2.    Patientswho had/have any periapical or odontogenic lesion associated with the impactedtooth.

3.    Patientknown to be allergic to any constituent of the proteolytic drug combination.

4.   Patients with a known allergy to co-amoxiclavgroup or NSAID drugs.

5.    Patients with any underlying systemiccondition/medication which will interfere with drug metabolism.

6.    Patients on immunosuppresants.

7.    Interincisal openingless than 3 cms.

PROCEDURE:

Patients will be selected from OPD ofNHDC, Mumbai. Detailed case history will be taken. Pre- operative medical &radiographic investigations will be done & informed consent will be taken.

All patients who are willing to participate in thestudy and are fit as per the inclusion criteria will be consecutively recruitedin the study. However, the distribution of a particular patient into aparticular group will be done on a random basis. The patients will be randomlydivided into the four groups using a randomisation generator from http://www.randomization.com/ that randomizes each subject into single treatmentby using the method of randomly permuted blocks

TotalNumber of patients – 200

Numberof operating surgeons – 1

Patientswill be randomly divided in four groups (50 patients in each group).All partially impacted mandibular third molars (upto Level B as per Pell andGregory Scales) requiring surgical extraction presenting to the OPD will beselected for the study.

Afterobtaining informed consent from the patient for the surgical procedure patientswill be kept blind about the group they are placed in. Operator who performsthe surgery is blind to the group that the patient is allotted in, observer isblind to the medicines that the patient has received.

Patientswill be sent for preoperative assessment of Hemoglobin, bleeding and clottingtime and an intraoral periapical radiograph of the impacted mandibular thirdmolar (if IOPA is not feasible then a lateral oblique view of the mandible willbe taken).

Antibioticshaving action over gram positive organisms (Amoxycillin 500mg three times aday) and NSAID’s (Diclofenac 50 mg and Paracetamol 500mg three times per day)available on the MCGM supply register will be provided to the patient as perhis group/subgroup; if there is shortage of the same then the investigatorsshall bore the cost of the same.

Group  ( Half an Hour Before meals)

|I – Antibiotics7 + Proteolyitc enzymes (started 48 hrs prior to surgery and continued for 3 days post surgery)

|II – Antibiotics + Proteolyitc enzymes (started on the day of surgery and continued for 5 days post surgery)

|III – Antibiotics + Proteolyitc enzymes (started immediately after surgery and continued for 5 days post surgery)

|IV – Antibiotics + Proteolyitc enzymes + NSAID’s1 (started 6 hours after surgery and continued as a 5 day post surgery regimen)

ClinicalParameters:

 1.   Proteolyticenzymes will be started 48 hours before surgery and continued 72 hours postsurgery in group 1.

2.   Ingroup III and IV no preoperativetherapy will be initiated and it will be given only postoperatively. The firstdose of the drug will be given immediatelyafter the surgery in group III andcontinued thereafter for next 5 days at an eight hourly interval.

3.   Painwill be evaluated by Visual Analog Scale on 1st day, 5thday, 7­th day after surgery. Use of analgesicwill be recorded.

4.   Facialswelling will be evaluated by measuring distance between 6 predetermined pointson 1st day, 5th day, 7­th day after surgery. The points will beCanthus (Cn) to Gnathion (Gn), corner of the mouth (Cm) to tragus of the ear(Tr) and Pogonion (Pg) to tragus (Tr).

5.   Postoperative quality of life of the patients will be evaluated on the basis of aquestionnaire which is prepared and patients will be asked to fill it up on 7thpost-op day.

6.   Anyother complications related to the surgery/lesion will be recorded.