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

Sponsor

Altamash Institute of Dental Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT05744726

Collaborator

Jinnah Postgraduate Medical Centre (Other)

129

Enrollment

Location

Arms

8.9

Anticipated Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

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].

Condition or Disease	Intervention/Treatment	Phase
Post-Extraction Socket Hemostasis Post-Extraction Socket Pain Relief Post-Extraction Socket Healing	Biological: A-PRF Combination Product: Bone-wax	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: A-PRF

Advance Platelet-Rich Fibrin

Biological: A-PRF

0.5 to 1g of Advance Platelet-Rich Fibrin (A-PRF) clot for each dental socket.

Active Comparator: Bone-wax

Combination Product: Bone-wax

0.5 to 1g of Bone-wax for each dental socket

Other Names:

combination of beeswax and other products

No Intervention: Conventional Dental Extraction protocol

Control Group

Outcome Measures

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.