Evaluation of Multilayered PRF in Comparison With Connective Tissue Graft by Sohn Poncho's Technique on Peri-implant Mucosal Enhancement in the Esthetic Zone

June 12, 2026 updated by: Gulf Medical University

Evaluation of Multilayered PRF in Comparison With Connective Tissue Graft by Sohn Poncho's Technique on Peri-implant Mucosal Enhancement in the Esthetic Zone. A Randomized Clinical Trial

An effective biological seal is crucial for protecting and supporting dental implants, particularly in the anterior region for the desired esthetic outcome.PRF membrane and CTG has been utilized to improve peri-implant soft tissue thickness and increase the width of keratinized tissue around dental implants. The stability of the PRF membrane is maintained by securing it with the healing abutment of the implant. While a few longitudinal studies have assessed the benefits of using PRF membrane with Sohn's Poncho technique in the posterior region, its effectiveness in the anterior region of the mouth remains to be evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

An effective biological seal is crucial for protecting and supporting dental implants, particularly in the anterior region for the desired esthetic outcome.13, 14 Recent studies have shown that the multilayering of the PRF membrane around implants have the same effect on peri-implant mucosal thickness in comparison to the gold standard which is the connective tissue graft without further patient morbidity 13, 14. PRF membrane and CTG has been utilized to improve peri-implant soft tissue thickness and increase the width of keratinized tissue around dental implants. The stability of the PRF membrane is maintained by securing it with the healing abutment of the implant. While a few longitudinal studies have assessed the benefits of using PRF membrane with Sohn's Poncho technique in the posterior region, its effectiveness in the anterior region of the mouth remains to be evaluated.7, 8 Additionally, the stabilized PRF membrane ensures prolonged exposure of the wound site to bioactive growth factors. Given these advantages, the potential benefits of using PRF membrane with dental implants in the anterior region need further exploration. Thus, this study focuses on comparing multilayering PRF membrane with the gold standard which is the CTG in healing period of 2nd stage implant surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Arab Emirates
    • Ajman Emirate
      • Ajman, Ajman Emirate, United Arab Emirates, 00000
        • Recruiting
        • Gulf Medical University
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

-Inclusion Criteria: Patients with single bounded missing tooth in the esthetic zone Patients in the age group of 21-65 years Patients having good oral hygiene (mean plaque score of < 25%) and with stable periodontal status.

-Exclusion Criteria: Smokers patients Patients with poor maintenance of oral hygiene, as determined by a mean plaque score of ≥ 25% despite efforts by the clinician to improve oral hygiene maintenance.

Patients with medically compromised conditions like uncontrolled diabetes mellitus or any systemic diseases that may result in compromised hard and soft tissue healing.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Platelet rich fibrin multilayered Platelet-rich fibrin (PRF) is a second-generation au
The test group will be treated with dental implant + multilayered PRF membrane. In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site. A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone. The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position. For the purposes of standardization, implants will be placed at subcrestal level in both the groups. In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment. Simple interrupted sutures will be used to approximate the tissues.
Procedure: Platelet rich fibrin multilayered Platelet-rich fibrin (PRF) A t the second stage
The test group will be treated with dental implant + multilayered PRF membrane. In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site. A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone. The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position. For the purposes of standardization, implants will be placed at subcrestal level in both the groups. In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment. Simple interrupted sutures will be used to approximate the tissues.
Active Comparator: Active Comparator: Connective Tissue Graft gingival grafting surgery that is done to enhance soft ti
The test group will be treated with dental implant + multilayered PRF membrane. In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site. A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone. The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position. For the purposes of standardization, implants will be placed at subcrestal level in both the groups. In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment. Simple interrupted sutures will be used to approximate the tissues.
Procedure: Soft tissue augmentation around dental implants with CTG in the second stage
The test group will be treated with dental implant and CTG. In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site. A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone. The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position. For the purposes of standardization, implants will be placed at subcrestal level in both the groups. In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment. Simple interrupted sutures will be used to approximate the tissues.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peri-implant soft tissue thickness
Time Frame: Time Frame: 6 weeks and 3 and 6 months
Volumetric
Time Frame: 6 weeks and 3 and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
width of the keratinized tissue around dental implants
Time Frame: Time Frame: baseline, 3 and 6 months
Periodontal probe mm
Time Frame: baseline, 3 and 6 months
Marginal bone loss
Time Frame: 6 months
CBCT measurement
6 months
Postoperative patient satisfaction VAS 0-5
Time Frame: baseline, 2 weeks, 6 months
VAS 0-5
baseline, 2 weeks, 6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gulf Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nesma MF Shemais, Assistant professor of Periodontology

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZainabMDSperio

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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Conditions

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