NCT06197893

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
Last Updated

January 11, 2024

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

December 26, 2023

Last Update Submit

January 9, 2024

Conditions

Keywords

Gingival unit graftSling sutureShrinkage

Outcome Measures

Primary Outcomes (1)

  • Graft shrinkage

    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 Outcomes (1)

  • Keratinized tissue weight gain (KTW)

    baseline, 1-, 3-months after FGG surgery

Other Outcomes (2)

  • Relative vestibule depth (rVD)

    baseline, 1-, 3-months after FGG surgery

  • Probing pocket depth (PD)

    baseline, 1-, 3-months after FGG surgery

Study Arms (4)

1. GUG+MSS

EXPERIMENTAL

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

2. GUG+CS

EXPERIMENTAL

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

3. CG+MSS

EXPERIMENTAL

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

4. CG+CS

EXPERIMENTAL

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

Interventions

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.

1. GUG+MSS

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.

2. GUG+CS

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.

3. CG+MSS

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.

4. CG+CS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Shakiliyeva S, Sahin D, Gunpinar S, Gursel M. Comparison of conventional and modified sling suture techniques in free gingival graft operations-a randomized controlled clinical trial. BMC Oral Health. 2025 Feb 21;25(1):279. doi: 10.1186/s12903-025-05456-x.

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Sadiye GUNPINAR

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Periodontology specialist

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 9, 2024

Study Start

March 15, 2022

Primary Completion

December 22, 2022

Study Completion

December 22, 2022

Last Updated

January 11, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

The authors can share the data upon reasonable request.

Locations