Modified Sling and Conventional Suture Techniques in Free Gingival Graft Operations

January 9, 2024 updated by: Sanubar Shakiliyeva, Bezmialem Vakif University

Comparison of Conventional and Modified Sling Suture Techniques In Free Gingival Graft Operations With CAIRO Type 2 and Type 3 Localized Gingival Recessions

The aim of this study is to investigate the effects of conventional suture (CS) and modified sling suture (MSS) techniques, applied in free gingival graft (FGG) surgery using gingival unit graft (GUG) and conventional graft (CG) techniques, on clinical parameters and graft dimensions.

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

Background: The aim of this study is to investigate the effects of conventional suture (CS) and modified sling suture (MSS) techniques, applied in free gingival graft (FGG) surgery using gingival unit graft (GUG) and conventional graft (CG) techniques, on clinical parameters and graft dimensions.

METHODS: 52 individuals having Cairo Type 2 (RT2) and Type 3 (RT3) gingival recessions in mandibular anterior region were divided into four groups as a) GUG+MSS (n=13), b) GUG+CS (n=13), c) CG+MSS (n=13) and d) CG+CS (n=13). Keratinized gingival width (KGW), keratinized tissue thickness (KGT), relative gingival recession height (rGRH), and relative vestibule depth (rVD) measurements were recorded using a digital caliper and periodontal probe UNC 15. Dimensional changes (Δ) of the graft surface area (GSA) was determined by ImageJ software. All measurements were done at baseline and repeated 1st and 3rd months.

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.
60

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

  • Turkey
      • Istanbul, Turkey
        • Bezmialem Vakıf 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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Systemically healthy individuals
  • <1 mm of attached gingiva on mandibular incisors
  • PI and GI scores <1
  • Patients who had not previously undergone soft tissue surgery in the relevant area

Exclusion Criteria:

  • Pregnant or lactating women
  • Patients younger than 18 years old
  • Mandibular incisors with having restoration, probing depth ≥ 3 mm, malposition and/or endodontic problem
  • Maxillary premolars with gingival recession in the palatal area and/or prosthetic restoration

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: Triple

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: 1. GUG+MSS
The GUG was obtained from the maxillary premolar area. The dissected graft was fixed to the recipient site using a modified sling suture technique.
Procedure: gingival unit graft+modified sling suture technique
The GUG was obtained from the maxillary premolar area. A sulcular incision including the marginal gingival tissue, and two vertical incisions, including the distal and mesial papillae, was made in the palatial parts of the premolars. Then, the incision lines were combined and a 1-1.5 mm thick graft of the desired dimensions was dissected. The dissected graft was fixed to the recipient site with 5/0 polypropylene suture using a modified sling suture technique. First, the needle was passed through the graft slightly apical to the mesial papilla on the buccal side and removed from the lingual aspect including lingual papilla. Subsequently, on the distal side, the needle was passed from the lingual side to the buccal side, and it was passed through the graft slightly apical to the distal papilla and removed from the lingual gingiva again. Then it was knotted on the buccal graft by returning to the buccal starting point on the mesial side.
Experimental: 2. GUG+CS
The GUG was obtained from the maxillary premolar area, as detailed experimental GUG+MSS group. The dissected graft was fixed to the recipient site using conventional suture technique.
Procedure: Gingival unit graft and conventional suture technique
The GUG was obtained from the maxillary premolar area. The dissected graft was fixed to the recipient site with 5/0 polypropylene suture using conventional suture technique. Conventional suture technique includes a horizontal matrix suture and 2 simple sutures. First the coronal part of the dissected graft was fixed to the recipient bed with a horizontal matrix suture, then with 2 simple sutures along the vertical incision line from mesial and distal sides with 5/0 polypropylene suture.
Experimental: 3. CG+MSS
Conventional graft dimensions were determined with aluminum foil and the foil was placed in the palatial region at the level of the maxillary premolars, at least 2 mm away from the free gingival margin of the adjacent teeth. The dissected graft was fixed to the recipient site with 5/0 polypropylene suture using a modified sling suture technique, as detailed experimental GUG+MSS group.
Procedure: Conventional graft and modified sling suture technique
Conventional graft dimensions were determined with aluminum foil and the foil was placed in the palatinal region at the level of the maxillary premolars, at least 2 mm away from the free gingival margin of the adjacent teeth. The exterier edges of the foil were drawn with a scalpel and the 1-1.5 mm thick graft was dissected from the donor site. The dissected graft was fixed to the recipient site with 5/0 polypropylene suture using a modified sling suture technique.
Experimental: 4. CG+CS
The dissected conventional graft, as detailed experimental CS+MSS group, fixed recipient bed with conventional suture technique, as detailed experimental GUG+CS group.
Procedure: Conventional graft and conventional suture technique
Conventional graft obtained from the palatinal region at the level of the maxillary premolars, at least 2 mm away from the free gingival margin of the adjacent teeth. The dissected graft was fixed to the recipient site with 5/0 polypropylene suture using conventional suture technique.

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
Graft shrinkage
Time Frame: baseline, 1-, 3-months after FGG surgery
The shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd months using ImageJ software.
baseline, 1-, 3-months after FGG surgery

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
Keratinized tissue weight gain (KTW)
Time Frame: baseline, 1-, 3-months after FGG surgery
Alginate impressions of each participants were taken from mandibular teeth and an acrylic stent containing both mandibular canine-canine teeth was prepared. The measurements were made relatively with reference to the predetermined points on the stent. KTW was measured as the distance from the buccal midpoint of tooth between the free gingival margin and the alveolar mucosa.
baseline, 1-, 3-months after FGG surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relative vestibule depth (rVD)
Time Frame: baseline, 1-, 3-months after FGG surgery
Alginate impressions of each participants were taken from mandibular teeth and an acrylic stent containing both mandibular canine-canine teeth was prepared. The measurements were made relatively with reference to the predetermined points on the stent. The distance between the reference point on the acrylic stent and mucogingival junction was considered as the relative vestibular depth.
baseline, 1-, 3-months after FGG surgery
Probing pocket depth (PD)
Time Frame: baseline, 1-, 3-months after FGG surgery
Probing pocket depth measured as the distance between the base of the pocket and the free gingival margin from the mesial, midbuccal and distal surfaces of the tooth belonging to the surgical site.
baseline, 1-, 3-months after FGG surgery

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.
Bezmialem Vakif 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: Sadiye GUNPINAR, Bezmialem Vakif 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.
March 15, 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.
December 22, 2022

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.
December 22, 2022

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).
December 26, 2023

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.
December 26, 2023

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.
January 9, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
January 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.
January 9, 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.
December 1, 2023

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.
  • SSHAKILIYEVA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The authors can share the data upon reasonable request.

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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