Comparison of A-PRF vs Bone Wax in Hemostasis, Pain Relief and Healing Following Exodontia

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the pain relief and healing effect of A-PRF and Bone-wax in patients having mandibular tooth-extractions. The main question[s] it aims to answer are: In the perspective of improvement in pain and healing; Does A-PRF performs better than control group? Does Bone-wax performs better than control group? Healing index and Pain scale score Comparison of A-PRF and Bone-wax; if one is better than the other? Participants will be asked to give resoponse to a post-operative symptom severiety (PoSSe) scale. An investigator will score the patient's extraction for hemostasis and on healing index [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items]. If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects].

Official Title
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Comparison of A-PRF vs Bone Wax in Hemostasis, Pain Relief and Healing Following Exodontia: A Single-blind Randomised Control Trial

Conditions
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Post-Extraction Socket Hemostasis, Post-Extraction Socket Healing, Post-Extraction Socket Pain Relief

Intervention / Treatment
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* Biological: A-PRF
* Combination Product: Bone-wax


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who need extraction of mandibular posterior teeth Overall, systemically healthy individuals (Established based on history, i.e., patients who do not take medicine for any systemic condition). INR within normal range. Exclusion Criteria: Patients with a diagnosed systemic condition. Patients who are immunocompromised. Patients who are unwilling to participate or withdraw from the study. Patients who fail to report on the seventh and twenty-first post-extraction day. Patients with physical or mental impairments who need assistance in taking their medications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A-PRF<br>Advance Platelet-Rich Fibrin | Biological: A-PRF<br>* 0.5 to 1g of Advance Platelet-Rich Fibrin (A-PRF) clot for each dental socket.<br>|
| Active Comparator: Bone-wax<br> | Combination Product: Bone-wax<br>* 0.5 to 1g of Bone-wax for each dental socket<br>* Other names: combination of beeswax and other products;|
| No Intervention: Conventional Dental Extraction protocol<br>Control Group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief on VAS | Patients receiving any of the intervention will be evaluated at just before, 3rd, 7th and 21st day of dental extraction on Visual Analogue Scale (VAS). | 21 days | 
| Extraction socket healing | Patients receiving any of the intervention will be evaluated at 3rd, 7th and 21st day of dental extraction on Healing index by Landry et al. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis | The post-operative bleeding will be evaluated 30 minutes after the placement of the last suture as: No bleeding Mild Bleeding: bleeding that stopped spontaneously or with minimal local compression. Severe Bleeding: bleeding that did not stop with the previous measures and that required local adrenaline or continuous local compression using gauze pack soaked in the corresponding antifibrinolytic agent until the bleeding stops | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet Rich Fibrin, Wound Healing, Tooth Extraction, Pain Severity, Bone wax