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

February 15, 2023 updated by: Rehan Ahmad, Altamash Institute of Dental Medicine

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

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].

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

129

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75510
        • Recruiting
        • Jinnah Postgraduate Medical Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rehan Ahmad, BDS
        • Sub-Investigator:
          • Jehan Alam, FCPS (OMFS)
        • Sub-Investigator:
          • Sabeen Masood, BDS
        • Sub-Investigator:
          • Rabia Arshad, PhD (Pharmacology)
        • Sub-Investigator:
          • Nabeel Naeem Baig, PhD (Public Health)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Relief on VAS
Time Frame: 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).
21 days
Extraction socket healing
Time Frame: 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.
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemostasis
Time Frame: 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
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Altamash Institute of Dental Medicine

Collaborators

Jinnah Postgraduate Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Estimate)

February 27, 2023

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F.2-81/2022-GENL/338/JPMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

As per institutional data privacy policy we are bound of not sharing patient data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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