Treatment of Gingival Recession With Tunnel Technique Using Connective Tissue Graft and Injectable Platelet Rich Fibrin

January 28, 2025 updated by: Suez Canal University

Treatment of Gingival Recession by Tunnel Technique Using Connective Tissue Graft With or Without Injectable Platelet Rich Fibrin: A Randomized Controlled Clinical Trial

Gingival recession is a common periodontal problem. Consequences include teeth sensitivity, poor esthetics and impaired oral hygiene access. Mild cases are managed by optimizing oral hygiene measures, correction of any causative factor such as faulty tooth brushing, improper dental restoration or denture clasp. Prescription of desensitization products such as specific tooth gels or mouth washes can manage the sensitivity problem. Deeper recession defects need to be addressed by surgical procedures. Coronally advanced flap with connective tissue graft is the gold standard procedure. However, it has some drawbacks due to the need for papillary incisions and vertical incisions in some cases. Within the era of minimally invasive periodontology, tunnel technique with connective tissue graft showed results comparable to coronally advanced flap with connective tissue graft but with some limitations. Addition of another agent may enhance the results of tunnel technique. Injectable platelet rich fibrin is known for its content of growth factors and effects on soft tissue healing. Aim: The study aim is to compare the surgical management of gingival recession with tunnel technique using connective tissue graft and injectable platelet rich fibrin to tunnel with connective graft without injectable platelet rich fibrin.

Methodology: 30 patients with miller class I or II gingival recession will be enrolled. 15 in the test group (Tunnel+ CTG+ i-PRF) and 15 in control group (Tunnel+ CTG). Clinical evaluation at 6 months

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

30 patients with miller class I/II gingival recession will be enrolled in this study.

15 patients will be treated using tunnel technique and palatal connective tissue graft inserted and sutured under the prepared tunnel after being soaked in injectable platelet rich fibrin for 15 minutes. The tunnel with the underlying graft will be advanced coronally. (Test Group) The other 15 patients will be treated the same way as in the first group but without soaking the graft in injectable platelet rich fibrin. (Control Group) Clinical parameters will be evaluated at baseline and 6 months follow-up except post-operative pain which will be assessed after 10 days. Histologic examination of small piece of the graft will be done to assess if there is true saturation of growth factors inside the graft.

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.
30

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

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

No

Description

Inclusion Criteria:

  • More than 21 years old
  • Systemically healthy
  • Presence of Miller class I/II gingival recession
  • Presence of identifiable CEJ

Exclusion Criteria:

  • Smoking
  • Systemic disease that contraindicates surgical procedures.
  • Poor compliance with oral hygiene measures
  • Necrotizing gingival conditions
  • Ongoing active periodontitis

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: Test group: tunnel with connective tissue graft and injectable platelet rich fibrin
Tunneling will be performed at the recession defect sites with insertion of palatal connective tissue graft taken from the patient hard palate inside the prepared tunnel. The graft will be soaked ,before insertion inside the tunnel, in injectable platelet rich fibrin ,prepared from patient own blood for 15 minutes. The tunnel with the soaked graft inside will be advanced coronally.
Procedure: Tunnel with connective tissue graft and injectable platelet rich fibrin
Tunnel with connective tissue graft and injectable platelet rich fibrin
Active Comparator: Control group: tunnel with connective tissue graft only
Tunnel preparation will be made in the recession defect sites with insertion of palatal connective tissue graft from the patient hard palate. The tunnel with the graft will be advanced coronally.
Procedure: Tunnel with connective tissue graft only
Tunnel technique with connective tossue graft only without injectable platelet rich fibrin

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
Recession depth
Time Frame: 6 months after the surgery
it will be recorded as the distance between the CEJ and gingival margin-measurements were performed at the mid-buccal aspect of the teeth, by manual probe and were rounded up to the nearest millimeter.
6 months after the surgery
Keratinized tissue height
Time Frame: 6 months
It will be measured from the mucogingival junction to the gingival margin-measurements were performed at the mid-buccal aspect of the teeth, by manual probe and were rounded up to the nearest millimeter.
6 months
Gingival thickness
Time Frame: 6 months
It will be measured at a mid-buccal location 1 mm apical to the probing depth level with an spreader. It will be pierced, perpendicularly to the mucosal surface, through the soft tissue with light pressure until a hard surface is felt. The silicone disk stop will then be placed in tight contact with the soft tissue surface. Penetration depth will be measured.
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
Post operative pain
Time Frame: 10 days
It will be measured by Visual analog Scale (VAS) with records from 0 to 10 with 0 means no pain and 10 means very severe pain. The patient will report the degree he experienced pain and choose a score from VAS.
10 days
Recession width
Time Frame: 6 months
It will be measured horizontally between the borders of the recession at the level of Cemento-enamel Junction.
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.
Suez Canal 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 Chair: Abdelnasser Elrefaey, Faculty of Dentistry, Suez Canal University
  • Study Director: Shaimaa Morsy, Faculty of Dentistry, Suez Canal 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)

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.
November 1, 2024

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.
June 1, 2025

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.
September 1, 2025

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).
October 3, 2024

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.
October 15, 2024

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.
October 17, 2024

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.
March 25, 2025

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.
January 28, 2025

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.
January 1, 2025

More Information

Terms related to this study

Keywords

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.
  • 486/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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