- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06197893
Modified Sling and Conventional Suture Techniques in Free Gingival Graft Operations
Comparison of Conventional and Modified Sling Suture Techniques In Free Gingival Graft Operations With CAIRO Type 2 and Type 3 Localized Gingival Recessions
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey
- Bezmialem Vakıf University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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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.
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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.
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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.
|
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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Graft shrinkage
Time Frame: baseline, 1-, 3-months after FGG surgery
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The shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd months using ImageJ software.
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baseline, 1-, 3-months after FGG surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Keratinized tissue weight gain (KTW)
Time Frame: baseline, 1-, 3-months after FGG surgery
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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.
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baseline, 1-, 3-months after FGG surgery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative vestibule depth (rVD)
Time Frame: baseline, 1-, 3-months after FGG surgery
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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.
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baseline, 1-, 3-months after FGG surgery
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Probing pocket depth (PD)
Time Frame: baseline, 1-, 3-months after FGG surgery
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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.
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baseline, 1-, 3-months after FGG surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sadiye GUNPINAR, Bezmialem Vakif University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSHAKILIYEVA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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