A Novel Vertical Y-shaped Tunnel Approach Versus Modified Coronally Advanced Tunnel Technique, for The Treatment of Miller Class I Gingival Recession

June 10, 2024 updated by: Aslam Ashraf Mogahed, October 6 University

A Novel Vertical Y-shaped Tunnel Approach Versus Modified Coronally Advanced Tunnel Technique, for The Treatment of Miller Class I Gingival Recession - Randomized Clinical Trial

Recent plastic procedures have provided satisfactory results in the treatment of gingival recession but there is, presently, a greater need for procedure that cause less surgical morbidity as also provide improved results. In this study we propose a novel vertical tunnel technique as a minimally invasive approach (Vertical Y-shaped Tunnel Approach) and evaluate clinical results in comparison to CAMT, both using CTG. The novel technique allows stability of the graft, maximum coronal vascularity and minimum soft tissue reflection.

Study Overview

Status

Status

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

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

The tunnel technique is an approach that optimizes esthetics and predictability because of its ability to avoid releasing critical papillae and maintaining a high level of vascularity at the surgical site to support the grafts. The tunnel technique has a minimally invasive nature since the interdental papillae are left intact and vertical incisions are not performed which results in better esthetics. This technique entailed the placement of a connective tissue graft in the tunnel. Complete graft coverage is not mandatory as long as the graft dimensions are sufficient to ensure its survival. Avoiding detachment of the highly fragile interdental soft tissue can minimize the risk of losing papilla height in critical esthetic areas, avoid scar formation, maximize the papillary and lateral blood supply to the underlying graft and better stabilize the graft for optimal wound healing Recent plastic procedures have provided satisfactory results in the treatment of gingival recession but there is, presently, a greater need for procedure that cause less surgical morbidity as also provide improved results. In this study we propose a novel vertical tunnel technique as a minimally invasive approach (Vertical Y-shaped Tunnel Approach) and evaluate clinical results in comparison to CAMT, both using CTG. The novel technique allows stability of the graft, maximum coronal vascularity and minimum soft tissue reflection.

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 (Actual)

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.
32

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 Locations

  • Egypt
      • Giza, Egypt
        • 6 October 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

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age above 18 years old.
  2. The presence of Miller's class I gingival recession (25).
  3. Recession defect on maxillary incisors, maxillary and mandibular canines, or premolars.
  4. Absence of a history of periodontal surgery at the involved sites in the last 12 months.
  5. History of compliance with oral hygiene instructions and periodontal recall.
  6. Sufficient palatal donor tissue thickness (> 2mm).
  7. Clearly identifiable cemento-enamel-junction (CEJ)

Exclusion Criteria:

  1. Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc (26).
  2. Pregnant and lactating women
  3. Current use of any form of tobacco.

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: root coverage using novel Y shaped Tunnel with Connective tissue graft
Sulcular incision will be performed using 15c blade . Micro-periosteal elevator will be used to elevate vertical full thickness tunnel starting coronally from the gingival sulcus and directed apically. Micro periosteal elevator will be used to elevate the buccal aspect of both mesial and distal papillae of the affected tooth. CTG will be prepared and inserted into the coronal tunnel aperture using blunt instrument to facilitate intrusion of graft into tunnel. CTG will be inserted into the tunnel up to the apical level leaving a coronal part to completely cover the recession defect. Finally single interrupted suture will be used to secure the coronal exposed part of the CTG followed by sling suture fixation of the gingival flap with that of CTG. The donor CTG will be stabilized to the underlying connective tissue interproximally using 5.0 sutures.
Procedure: Y shaped Tunnel with Connective tissue graft
Sulcular incision followed by Micro-periosteal elevator will be used to elevate vertical full thickness tunnel starting coronally from the gingival sulcus and directed apically. CTG will be prepared and inserted into the coronal tunnel aperture using blunt instrument to facilitate intrusion of graft into tunnel. CTG insurted into the tunnel up to the apical level leaving a coronal part to completely cover the recession defect. Finally single interrupted suture will be used to secure the coronal exposed part of the CTG followed by sling suture fixation of the gingival flap with that of CTG. The donor CTG will be stabilized to the underlying connective tissue interproximally using 5.0 sutures.
Active Comparator: root coverage using MCAT with Connective tissue graft
The tunnel will be prepared with a full-thickness incision up to MGJ and as a split-thickness beyond MGJ using tunneling instruments to obtain a tension-free tunnel, allowing the insertion of the CTG, a delicate incision is performed at the level of interdental papillae and raised without detaching the tip of the papillae. The papillary regions will be detached in their buccal aspects. The adjacent papillae of the neighboring teeth will be involved in the preparation to ensure a coronal positioning of the flap. After planing, the graft will be inserted into the tunnel by a specific suture technique. The first suture will be inserted through the most distal recession part and the needle exits in the most medial part of the recession, second suture will be placed at the opposite side and the needle exits at the same medial recession. The buccal flap will be advanced coronally to cover CTG and secured with sling sutures. The donor CTG will stabilized to the underlying CT interproximally.
Procedure: Y shaped Tunnel with Connective tissue graft
Sulcular incision followed by Micro-periosteal elevator will be used to elevate vertical full thickness tunnel starting coronally from the gingival sulcus and directed apically. CTG will be prepared and inserted into the coronal tunnel aperture using blunt instrument to facilitate intrusion of graft into tunnel. CTG insurted into the tunnel up to the apical level leaving a coronal part to completely cover the recession defect. Finally single interrupted suture will be used to secure the coronal exposed part of the CTG followed by sling suture fixation of the gingival flap with that of CTG. The donor CTG will be stabilized to the underlying connective tissue interproximally using 5.0 sutures.

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
percentage of root coverage
Time Frame: 1 month, 3 and 6 months
Percentage root coverage (%RC): calculated as ([RD preoperative - RD postoperative]/RD preoperative) × 100%.
1 month, 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
Complete root coverage (CRC)
Time Frame: 1 month, 3 and 6 months
The number of sites that resulted in 100% root coverage.
1 month, 3 and 6 months
Recession Depth (RD)
Time Frame: 1 month, 3 and 6 months
Measured in millimeters from the gingival margin at the midbuccal aspect of the root, to the CEJ or relative CEJ.
1 month, 3 and 6 months
Recession width (RW)
Time Frame: 1 month, 3 and 6 months
The horizontal distance between the bilateral gingival margins at the height of the CEJ. (mm)
1 month, 3 and 6 months
Probing depth (PD)
Time Frame: 6 months
Measured in millimeters from the gingival margin to the base of the periodontal sulcus at 6 sites per tooth. (baseline and after 6 months)
6 months
Clinical attachment level (CAL)
Time Frame: 6 months
Measured in millimeters from CEJ or relative CEJ to the base of the periodontal sulcus at 6 sites per tooth. (after 6 months)
6 months
Width of the keratinized tissue (KTW)
Time Frame: 1 month, 3 and 6 months
Measured in millimeters at midbuccal aspect of the tooth from the gingival margin to the mucogingival junction.
1 month, 3 and 6 months
Gingival Thickness (GT)
Time Frame: 6 months
Measured in millimeters at the mid-buccal of the gingiva and 2 mm apical the gingival margin at the attached gingiva or the alveolar mucosa using a #15 endodontic reamer with a silicon disk stop.
6 months
Plaque index (PI)
Time Frame: 1 month, 3 and 6 months
Is used for estimating the status of oral hygiene by measuring dental plaque that occurs in the areas adjacent to the gingival margin.
1 month, 3 and 6 months
Gingival index (GI)
Time Frame: 1 month, 3 and 6 months
GI is measured according to Loe and Sillness and scored on a scale of 0 to 3.
1 month, 3 and 6 months
Pain index (PN)
Time Frame: 1 month, 3 and 6 months
Pain is recorded on a horizontal pain scale of 0-10, Pain index to be recorded by the patients at 9 am, 3pm, and 9 pm from the day of the surgery and for 3 weeks post-treatment.
1 month, 3 and 6 months
Professional esthetic evaluation and patient-reported satisfaction
Time Frame: 6 months

The esthetic outcome will be assessed post-operatively after 6 months by an independent second examiner (MS), who is blinded to the treatment assignment, in accordance with RES (30). The evaluation will be based on comparing digital photographs.

Five variables were assessed:

  1. the level of gingival margin (GM);
  2. marginal tissue contour (MTC);
  3. soft tissue texture (STT);
  4. muco-gingival junction alignment (MGJ); and
  5. gingival color (GC). A score of 0, 3, or 6 will be used for evaluation of GM, whereas a score of 0-1 will be used for each of the other variables. The ideal esthetic score will be 10.
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.
October 6 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.
  • Principal Investigator: Aslam Ashraf Mogahed, BDs, O6U

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.
March 2, 2022

Primary Completion (Actual)

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.
February 4, 2024

Study Completion (Actual)

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 4, 2024

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).
May 7, 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.
June 10, 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.
June 11, 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.
June 11, 2024

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 10, 2024

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, 2024

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.
  • 14-2022

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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