3D Analysis of Soft Tissue Healing After Immediate Implant Placement Using PRF Vs HAM

February 14, 2025 updated by: Ain Shams University

3D Analysis of Soft Tissue Healing After Immediate Implant Placement in Molar Sites Using PRF Vs HAM: a Randomized Controlled Clinical Study in Molar Sites Using PRF Vs HAM: a Randomized Controlled Clinical Study

Statement of the problem: Soft tissue healing following immediate implant placement is one of the major factors that affect implant restoration, function & success.

Aim: The aim of this study is to compare the effect of using HAM (Human amniotic membrane) and platelet rich fibrin (PRF) in soft tissue healing with immediate implant placement in the molar region.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim: The aim of this study is to compare the effect of using HAM (Human amniotic membrane) and platelet rich fibrin (PRF) in soft tissue healing with immediate implant placement in the molar region.

Materials and Methods: This parallel arm, randomized controlled clinical trial will involve systemically free patients with remaining roots or badly decayed teeth in molar sites region requiring implant placement. They will be randomly allocated to three equal groups. Group A (test group, n=12) will receive immediate implants (grafting with PRF), group B (test group, n=12) will receive immediate implants (grafting with HAM) and group c (test group, n=12) will receive immediate implants (no grafting). After implant placement, soft tissue healing (1ry outcome) and postoperative pain (2nd outcome) will be assessed. The parameters will be assessed at baseline, every day for the first week, day after day second week, once in third and fourth week. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

Study Type

Interventional

Enrollment (Estimated)

36

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

  • Egypt
      • Cairo, Egypt, 123456
        • faculty of oral and dental medicine , Suez university

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients at least 18 years old, with non-restorable first and second molars.
  2. Minimum remaining alveolar height of four to six millimeters distance from the apex of the socket to the floor of maxillary sinus for maxillary teeth and minimum remaining alveolar height of six millimeters distance from the apex of the socket to the inferior alveolar nerve for mandibular teeth.
  3. Minimum alveolar Bucco-palatal dimension of 7 mm.

Exclusion Criteria:

  1. Patients with known systemic diseases which can affect normal bone formation or blood coagulation.
  2. Patients who are smokers.
  3. Presence of signs of active infection or pus formation.
  4. Absence or loss of buccal wall prior to implant placement.
  5. Bad oral hygiene

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Grafting with PRF
immediate implant will be placed and PRF membrane will be placed into the soft tissue. The PRF plug will be maintained in place with approximating sutures using 5-0 resorbable suture material.
Procedure: PRF
PRF membrane will be used for soft tissue grafting around implant
Active Comparator: Grafting using Human amniotic membrane (HAM)
immediate implant placement will be done and The HAM plug will be placed into the soft tissue.
Procedure: Human amniotic membrane
Human amniotic membrane will be used for soft tissue grafting around implan
Active Comparator: No Grafting
Immediate implant placement will be done and with no soft tissue grafting
Procedure: No grafting
No soft tissue grafting around implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue healing
Time Frame: Baseline, every day for the first week, day after day second week, once in third and fourth week
Surface area/intraoral scanner
Baseline, every day for the first week, day after day second week, once in third and fourth week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative pain
Time Frame: Baseline, every day for the first week, day after day second week, once in third and fourth week
Visual analog scale: numerical scale in which 0 is no pain and 10 is maximum pain
Baseline, every day for the first week, day after day second week, once in third and fourth week

Collaborators and Investigators

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

Sponsor

Ain Shams University

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 7, 2025

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3D soft tissue assessment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Badly Broken Maxillary Premolars Indicated for Extraction

Clinical Trials on PRF

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe