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

Not Applicable

Recruiting

• Conditions: Post-Extraction Socket Hemostasis; Post-Extraction Socket Pain Relief; Post-Extraction Socket Healing
• Interventions: Biological: A-PRF; Combination Product: Bone-wax

• Registration Number: NCT05744726
• Lead Sponsor: Altamash Institute of Dental Medicine

Brief Summary

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 \[insert effects\].

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-01-12
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-15
• Last Update Submitted: 2023-02-15
• Study First Posted: 2023-02-27
• Last Update Posted: 2023-02-27
• Primary Completion: 2023-06-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 129

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A-PRF	A-PRF	Advance Platelet-Rich Fibrin
Bone-wax	Bone-wax	-

Primary Outcome Measures

Name	Time	Method
Extraction socket healing	21 days	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.
Pain Relief on VAS	21 days	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).

Secondary Outcome Measures

Name	Time	Method
Hemostasis	30 minutes	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

Trial Locations

Locations (1)

Jinnah Postgraduate Medical Centre; 🇵🇰 Karachi, Sindh, Pakistan