Gingival Recession, LocalizedNCT06197893
Modified Sling and Conventional Suture Techniques in Free Gingival Graft Operations
A study testing gingival unit graft+modified sling suture technique, Gingival unit graft and conventional suture technique and Conventional graft and modified sling suture technique in people with Gingival Recession, Localized, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Localized
- What is being tested?
- gingival unit graft+modified sling suture technique, Gingival unit graft and conventional suture technique and Conventional graft and modified sling suture technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 22 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingival Recession, Localized
- Being tested
- gingival unit graft+modified sling suture technique, Gingival unit graft and conventional suture technique, Conventional graft and modified sling suture technique, Conventional graft and conventional suture technique
- Keywords
- Gingival unit graft, Sling suture, Shrinkage
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gingival unit graft+modified sling suture techniqueProcedure or surgery
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.
Gingival unit graft and conventional suture techniqueProcedure or surgery
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.
Conventional graft and modified sling suture techniqueProcedure or surgery
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.
Conventional graft and conventional suture techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Conventional graft and conventional suture technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 1-, 3-months after FGG surgery
Secondary outcomes (1)
Keratinized tissue weight gain (KTW)
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.
Measured: baseline, 1-, 3-months after FGG surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start15 Mar 2022
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival Recession, LocalizedStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanubar Shakiliyeva, Bezmialem Vakif University
- Investigators
- Sadiye GUNPINAR, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197893
- Sponsor's protocol ID
- SSHAKILIYEVA
- Status last verified
- Dec 2023
- First submitted
- 26 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The authors can share the data upon reasonable request.
Publications
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.
PubMed 39984903
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional and Modified Sling Suture Techniques In Free Gingival Graft Operations With CAIRO Type 2 and Type 3 Localized Gingival Recessions
- ClinicalTrials.gov ID
- NCT06197893
- Acronym / sponsor ID
- SSHAKILIYEVA
- Conditions
- Gingival Recession, Localized
- Keywords
- Gingival unit graft, Sling suture, Shrinkage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. GUG+MSS | Experimental | Procedure: gingival unit graft+modified sling suture techniqueThe GUG was obtained from the maxillary premolar area. The dissected graft was fixed to the recipient site using a modified sling suture technique. |
| 2. GUG+CS | Experimental | Procedure: Gingival unit graft and conventional suture techniqueThe 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. |
| 3. CG+MSS | Experimental | Procedure: Conventional graft and modified sling suture techniqueConventional 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. |
| 4. CG+CS | Experimental | Procedure: Conventional graft and conventional suture techniqueThe dissected conventional graft, as detailed experimental CS+MSS group, fixed recipient bed with conventional suture technique, as detailed experimental GUG+CS group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gingival unit graft+modified sling suture techniqueThe 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. | Procedure or surgery | 1. GUG+MSS |
| Gingival unit graft and conventional suture techniqueThe 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. | Procedure or surgery | 2. GUG+CS |
| Conventional graft and modified sling suture techniqueConventional 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. | Procedure or surgery | 3. CG+MSS |
| Conventional graft and conventional suture techniqueConventional 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. | Procedure or surgery | 4. CG+CS |
Primary outcome
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.
1 secondary outcome
Keratinized tissue weight gain (KTW)
Time frame: baseline, 1-, 3-months after FGG surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Derived from this study: PubMed 39984903Shakiliyeva 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.
- Individual participant dataSharing planned: No. The authors can share the data upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sadiye GUNPINAR principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gingival unit graft+modified sling suture technique, Gingival unit graft and conventional suture technique and Conventional graft and modified sling suture technique in people with Gingival Recession, Localized, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft shrinkage (time frame: baseline, 1-, 3-months after FGG surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06197893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.