Effectiveness of Gelatamp in Wound Healing After Teeth Extraction: A Randomized Clinical Trial

Study Overview
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Brief Summary
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This study compares the effectiveness of Gelatamp for intraoral wound closure after extraction of mandibular teeth.

Detailed Description
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In the interventional group, after extraction of mandibular teeth, the extraction socket will be augmented with Gelatamp. Then a gauze pack will be placed over it. In the control group, after extraction of mandibular teeth, a gauze pack will be placed over the socket.

Official Title
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Effectiveness of Gelatamp in Wound Healing After Extraction of Teeth: A Randomized Clinical Trial

Conditions
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Wound Heal

Intervention / Treatment
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* Drug: Colloidal silver gelatin sponge
* Drug: Sterile gauze pack


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring extraction of mandibular teeth Healthy patients (ASA I) or patients with mild systemic disease but no functional limitations (ASA II) Patients not allergic to the drugs or anesthetics used in the study. Exclusion Criteria: Patients taking medications that influences wound healing smokers Uncooperative patients Patients requiring extraction of grade II or III mobile teeth Patients requiring surgical extraction of teeth.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Application of Gelatamp in the extraction socket | Drug: Colloidal silver gelatin sponge<br>* Augment the extraction socket with Gelatamp<br>* Other names: Gelatamp;|
| Active Comparator: Group B<br>Extraction socket allowed to heal without application of Gelatamp | Drug: Sterile gauze pack<br>* Extraction socket allowed to heal without augmentation with any material<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative wound healing | A 5 point early wound healing scale assessing wound healing after 7 postoperative days | 7th postoperative day | 
| Postoperative pain | A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain). | 1st postoperative day | 
| Postoperative pain | A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain). | 2nd postoperative day | 
| postoperative pain | A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain). | 3rd postoperative day | 
| postoperative pain | A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain). | 4th postoperative day | 
| postoperative pain | A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain). | 5th postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of dry socket | presence of pain, foul odour, exposed bone in the extraction socket | 3rd postoperative day |