Clinical trial to study the effect of a combination of propolis, vitamin C and vitamin E on the wound healing after wisdom tooth surgery.

Phase 3

Not yet recruiting

Brief Summary: THIS STUDY AIMS TO EVALUATE THE EFFECTIVENESS OF A BIO-COMPATIBLE, BIO-OCCLUSIVE GEL CONTAINING A NANO-EMULSION OF PROPOLIS, VITAMIN C AND VITAMIN E AFTER IMPACTED MANDIBULAR THIRD MOLAR SURGERY. 40 SUBJECTS SELECTED ACCORDING TO INCLUSION AND EXCLUSION CRITERIA, WILL BE RANDOMLY ASSIGNED USING THE LOTTERY METHOD TO THE INTERVENTION GROUP WHEREIN THEY WILL UNDERGO AN ATRAUMATIC SURGICAL EXTRACTION OF MANDIBULAR IMPACTED THIRD MOLAR. THE EXTRACTION WOUND WILL BE DEBRIDED AND PLACED WITH AN ABSORBABLE GELATIN FOAM IMPREGNATED WITH THE INTERVENTION GEL AND CLOSED PRIMARILY. THE COMPARATOR GROUP AFTER A WASH OUT PERIOD OF 2 WEEKS WILL UNDERGO IMPACTED MANDIBULAR THIRD MOLAR SURGERY ON THE CONTRA-LATERAL SIDE FOLLOWED BY INTRA-ALVEOLAR PLACEMENT OF PLAIN ABSORBABLE GELATIN FOAM AND WOUND WILL BE SUTURED. THE PRIMARY OUTCOME IS THE WOUND HEALING TO BE ASSESSED CLINICALLY ON POST-OPERATIVE DAY 1 AND 3 AND NOTED DOWN USING A WOUND HEALING INDEX.THE SECONDARY OUTCOME WILL BE THE PAIN ASSESSMENT ON VISUAL ANALOGUE SCALE OF 0-10. 0 IS A SCORE OF NO PAIN AND 10 IS A SCORE OF INTOLERABLE PAIN.

Recruitment & Eligibility

Inclusion Criteria

1)patients being 18 to 30 years of age with an indication for bilateral extraction of impacted mandibular third molars. The surgery difficulty index to range preferably between 7 and 10 according to the Pederson scale (being equal on both sides). 2)Good physical status (ASA Status I and II) 3)surgery completed within 30 minutes 4)absence of infection.
local and systemic 5) no antibiotics and analgesics consumed 7 days prior to surgery 6)consenting patients to undergo procedure and follow up post-operatively.

Exclusion Criteria

Known systemic disease like diabetes, hypertension, thyroid disorders, etc 2)febrile patients with infection 3)Known drug and food allergies 4)Pregnancy and lactation 5)patients taking antipsychotic, sedatives, anti-coagulants,etc 6)Immunosuppresion 7)Pain of odontogenic origin, oral ulcers, cysts.

Primary Outcome Measures

Name	Time	Method
Wound healing to be seen on 1st and 3rd operative day.	Wound healing to be seen on 1st and 3rd operative day. \| Presence or absence of dry socket to be detected.
Presence or absence of dry socket to be detected.	Wound healing to be seen on 1st and 3rd operative day. \| Presence or absence of dry socket to be detected.

Secondary Outcome Measures

Name	Time	Method
Pain to be evaluated on Visual Analogue Scale of 0-10 where 0 is no pain and a score of 10 is intolerable pain

Locations (1): DR GD POL FOUNDATIONS YMT DENTAL COLLEGE AND HOSPITAL
🇮🇳
Raigarh, MAHARASHTRA, India
DR GD POL FOUNDATIONS YMT DENTAL COLLEGE AND HOSPITAL
🇮🇳Raigarh, MAHARASHTRA, India
DR KARISHMA MOTWANI
Principal investigator
9820398688
karishma.motwani05@gmail.com