Gingival Recession, LocalizedNCT06404762
Tuberosity Versus Palatal Connective Tissue Graft on the Treatment of Single Maxillary Recession-type Defects
A study testing tSCTG+ CAF and pSCTG+ CAF in people with Gingival Recession, Localized, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized clinical study is to assess the root coverage outcomes and patient morbidity following the treatment of single maxillary recession-type defects using a coronally advanced flap (CAF) combined with a subepithelial connective tissue graft (SCTG) harvested from the maxillary tuberosity (MT)… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Localized
- What is being tested?
- tSCTG+ CAF and pSCTG+ CAF
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 1 Oct 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoker, systemically healthy
- No active periodontal disease
- Maxillary anterior and premolar teeth with single, isolated recessions RT 1 (Miller 1 \&2)
- Absences of non-carious cervical lesions (NCCL) and non-detectable cemento-enamel junction (CEJ)
- Buccal gingival recession defects between 2-5 mm in depth
Who cannot join
- Presence of caries lesions or restorations in the cervical area
- Intake of medications that impede periodontal tissue health and healing
- Medical contraindications for periodontal surgical procedures
- Pregnancy and lactation
- Bleeding and plaque scores ≥ 20%
- Probing depths > 4 mm
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Dentistry
Ankara, Çankaya, 06490
About this study
Official title: Comparison of Subepithelial Connective Tissue Grafts Harvested From the Maxillary Tuberosity or Lateral Palate in the Treatment of Single Maxillary Recession-type Defects
The goal of this randomized clinical study is to assess the root coverage outcomes and patient morbidity following the treatment of single maxillary recession-type defects using a coronally advanced flap (CAF) combined with a subepithelial connective tissue graft (SCTG) harvested from the maxillary tuberosity (MT) versus lateral palate (LP). The secondary objective is to evaluate the histological characteristics of graft compositions harvested from the different regions (MT versus LP).
Therefore, the following questions related to the study are raised:
Read more
- Do SCTGs harvested from MT (tSCTG) and LP (pSCTG) exhibit similar root coverage outcomes in the treatment of single maxillary recession-type defects using CAF?
- What are the histological characteristics of tSCTG and pSCTG?
A total of 30 patients who have been referred to the Gazi University Department of Periodontology will be randomly assigned to receive tSCTG or pSCTG in combination with CAF. Clinical measurements will be recorded at baseline, 1, 3, 6, and 12 months after surgeries. Immediately after interventions; a questionnaire evaluating post-operative pain, discomfort, sensitivity, and bleeding will be given to the patients. The amount of non-steroid anti-inflammatory drugs used will be recorded at 1, 2, 3, 7, 14 and 28 days after surgery. Descriptive morphologic analysis of the grafts will be assessed in terms of the presence of inflammatory cells, connective tissue cellularity, vascularization, adipose tissue, and collagen structure.
Read the detailed description
The treatment of gingival recessions using the coronally advanced flap (CAF) in combination with palatal subepithelial connective tissue graft (pSCTG) is highly predictable and frequently accepted in periodontal plastic-aesthetic surgeries. However, due to its limitations and disadvantages, clinicians often use grafts harvested from different autogenous areas or multiple non-autogenous materials as an alternative.
CAF combined with pSCTG is considered the gold standard for root coverage procedures. However, factors such as the density of vascular structures, a close approximation to nerves, and postoperative morbidity remain concerning for clinicians using palatal connective tissue grafts. Because of this, researchers have sought different techniques for palatal connective tissue harvesting and/or different autogenous donor areas. The maxillary tuberosity region has been found to have a denser lamina propria and is farther from nerve/vascular bundles.
Despite differences in harvesting techniques, literature has presented similar root coverage outcomes, lesser post-operative bleeding, and pain for SCTGs harvested from the maxillary tuberosity (tSCTG) compared to pSCTG groups. Decreased post-operative pain after tSCTG harvesting could be explained by higher amounts of connective tissue present in the donor area after harvesting and avoiding trauma created by food consumption and tongue movements in the region. Clinical data also showed an increased amount of keratinized tissue and its stability after augmentation, favoring tSCTG. Considering structural differences, literature has shown that tSCTG provides more thickness, a more abundant lamina propria, and denser collagen compared to pSCTG. However, due to the size of the harvested tSCTG not being as abundant as pSCTG, it can be assumed that the augmented areas were limited to multiple recessions or defects.
- Conditions
- Gingival Recession, Localized
- Being tested
- tSCTG+ CAF, pSCTG+ CAF
- Keywords
- Maxillary Tuberosity, Connective Tissue Graft, Coronally Advanced Flap
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tSCTG+ CAFProcedure or surgery
In the tSCTG group, at the distal end of a second maxillary molar, an incision will be made using a double-bladed scalpel (SKU 10-130-05D; Hu-Friedy, Chicago, IL, USA) bucco-palatally, forming a 1,5 mm thick parallel line. Secondary incisions will be made to separate the graft using a 15c blade on the buccal and palatal sides. Later, the graft will be de-epithelialized extra-orally using a blade
pSCTG+ CAFProcedure or surgery
In pSCTG group; the graft will be harvested through a single-incision approach at the lateral palatal mucosa
| Study group | Role | What they receive |
|---|---|---|
| tSCTG+ CAF | Active comparator | Single, isolated gingival recessions; excluding molars; at maxilla will be treated with subepithelial connective tissue graft harvested from the maxillary tuberosity in conjunction with a coronally advanced flap Receives: Procedure: tSCTG+ CAF |
| pSCTG+ CAF | Active comparator | Single, isolated gingival recessions; excluding molars; at maxilla will be treated with subepithelial connective tissue graft harvested from the lateral palate in conjunction with a coronally advanced flap Receives: Procedure: pSCTG+ CAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of root coverage
Mean root coverage of tSCTG versus pSCTG with CAF according to the gingival recession changes from baseline and the 1-year postoperative follow-up
Measured: 1-year postoperative follow-up
Secondary outcomes (6)
The percentage of complete root coverage
After the 1-year postoperatively, absence of gingival recession
Measured: 1-year postoperative follow-up
Recession depth
The distance between cemento-enamel junction and gingival margin
Measured: 1-year postoperative follow-up
Patient morbidity - Postoperative pain
Postoperative pain will be assessed using a visual analogue score
Measured: Up to 28 days postoperatively
Patient morbidity - Postoperative discomfort
Postoperative discomfort will be assessed using a visual analogue score
Measured: Up to 28 days postoperatively
Histological features of the graft
Graft cellularity
Measured: Through study completion, an average of 1 year
Histomorphometrical features of the graft
The amount of lamina propria
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jul 2023
- Primary completion1 Sep 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Gazi 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
- Model description
- Randomized controlled clinical study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sıla Çağrı İşler, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404762
- Sponsor's protocol ID
- E-21071282-050.99-519910
- Status last verified
- Feb 2026
- First submitted
- 5 May 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zucchelli G, Amore C, Sforza NM, Montebugnoli L, De Sanctis M. Bilaminar techniques for the treatment of recession-type defects. A comparative clinical study. J Clin Periodontol. 2003 Oct;30(10):862-70. doi: 10.1034/j.1600-051x.2003.00397.x.
PubMed 14710766Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.
PubMed 25644302Jung UW, Um YJ, Choi SH. Histologic observation of soft tissue acquired from maxillary tuberosity area for root coverage. J Periodontol. 2008 May;79(5):934-40. doi: 10.1902/jop.2008.070445.
PubMed 18454674Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.
PubMed 20590963
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Subepithelial Connective Tissue Grafts Harvested From the Maxillary Tuberosity or Lateral Palate in the Treatment of Single Maxillary Recession-type Defects
- ClinicalTrials.gov ID
- NCT06404762
- Acronym / sponsor ID
- E-21071282-050.99-519910
- Conditions
- Gingival Recession, Localized
- Keywords
- Maxillary Tuberosity, Connective Tissue Graft, Coronally Advanced Flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 8 May 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 goal of this randomized clinical study is to assess the root coverage outcomes and patient morbidity following the treatment of single maxillary recession-type defects using a coronally advanced flap (CAF) combined with a subepithelial connective tissue graft (SCTG) harvested from the maxillary tuberosity (MT) versus lateral palate (LP). The secondary objective is to evaluate the histological characteristics of graft compositions harvested from the different regions (MT versus LP).
Therefore, the following questions related to the study are raised:
- Do SCTGs harvested from MT (tSCTG) and LP (pSCTG) exhibit similar root coverage outcomes in the treatment of single maxillary recession-type defects using CAF?
- What are the histological characteristics of tSCTG and pSCTG?
A total of 30 patients who have been referred to the Gazi University Department of Periodontology will be randomly assigned to receive tSCTG or pSCTG in combination with CAF. Clinical measurements will be recorded at baseline, 1, 3, 6, and 12 months after surgeries. Immediately after interventions; a questionnaire evaluating post-operative pain, discomfort, sensitivity, and bleeding will be given to the patients. The amount of non-steroid anti-inflammatory drugs used will be recorded at 1, 2, 3, 7, 14 and 28 days after surgery. Descriptive morphologic analysis of the grafts will be assessed in terms of the presence of inflammatory cells, connective tissue cellularity, vascularization, adipose tissue, and collagen structure.
Detailed description
The treatment of gingival recessions using the coronally advanced flap (CAF) in combination with palatal subepithelial connective tissue graft (pSCTG) is highly predictable and frequently accepted in periodontal plastic-aesthetic surgeries. However, due to its limitations and disadvantages, clinicians often use grafts harvested from different autogenous areas or multiple non-autogenous materials as an alternative.
CAF combined with pSCTG is considered the gold standard for root coverage procedures. However, factors such as the density of vascular structures, a close approximation to nerves, and postoperative morbidity remain concerning for clinicians using palatal connective tissue grafts. Because of this, researchers have sought different techniques for palatal connective tissue harvesting and/or different autogenous donor areas. The maxillary tuberosity region has been found to have a denser lamina propria and is farther from nerve/vascular bundles.
Despite differences in harvesting techniques, literature has presented similar root coverage outcomes, lesser post-operative bleeding, and pain for SCTGs harvested from the maxillary tuberosity (tSCTG) compared to pSCTG groups. Decreased post-operative pain after tSCTG harvesting could be explained by higher amounts of connective tissue present in the donor area after harvesting and avoiding trauma created by food consumption and tongue movements in the region. Clinical data also showed an increased amount of keratinized tissue and its stability after augmentation, favoring tSCTG. Considering structural differences, literature has shown that tSCTG provides more thickness, a more abundant lamina propria, and denser collagen compared to pSCTG. However, due to the size of the harvested tSCTG not being as abundant as pSCTG, it can be assumed that the augmented areas were limited to multiple recessions or defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| tSCTG+ CAF | Active comparator | Procedure: tSCTG+ CAFSingle, isolated gingival recessions; excluding molars; at maxilla will be treated with subepithelial connective tissue graft harvested from the maxillary tuberosity in conjunction with a coronally advanced flap |
| pSCTG+ CAF | Active comparator | Procedure: pSCTG+ CAFSingle, isolated gingival recessions; excluding molars; at maxilla will be treated with subepithelial connective tissue graft harvested from the lateral palate in conjunction with a coronally advanced flap |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-smoker, systemically healthy
- No active periodontal disease
- Maxillary anterior and premolar teeth with single, isolated recessions RT 1 (Miller 1 \&2)
- Absences of non-carious cervical lesions (NCCL) and non-detectable cemento-enamel junction (CEJ)
- Buccal gingival recession defects between 2-5 mm in depth
Key exclusion criteria (6 listed)
- Presence of caries lesions or restorations in the cervical area
- Intake of medications that impede periodontal tissue health and healing
- Medical contraindications for periodontal surgical procedures
- Pregnancy and lactation
- Bleeding and plaque scores ≥ 20%
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 |
|---|---|---|
| tSCTG+ CAFIn the tSCTG group, at the distal end of a second maxillary molar, an incision will be made using a double-bladed scalpel (SKU 10-130-05D; Hu-Friedy, Chicago, IL, USA) bucco-palatally, forming a 1,5 mm thick parallel line. Secondary incisions will be made to separate the graft using a 15c blade on the buccal and palatal sides. Later, the graft will be de-epithelialized extra-orally using a blade | Procedure or surgery | tSCTG+ CAF |
| pSCTG+ CAFIn pSCTG group; the graft will be harvested through a single-incision approach at the lateral palatal mucosa | Procedure or surgery | pSCTG+ CAF |
Primary outcome
The percentage of root coverage
Time frame: 1-year postoperative follow-up
Mean root coverage of tSCTG versus pSCTG with CAF according to the gingival recession changes from baseline and the 1-year postoperative follow-up
6 secondary outcomes
The percentage of complete root coverage
Time frame: 1-year postoperative follow-up
Recession depth
Time frame: 1-year postoperative follow-up
Patient morbidity - Postoperative pain
Time frame: Up to 28 days postoperatively
Patient morbidity - Postoperative discomfort
Time frame: Up to 28 days postoperatively
Histological features of the graft
Time frame: Through study completion, an average of 1 year
Histomorphometrical features of the graft
Time frame: Through study completion, an average of 1 year
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 2 Mar 2026.
- Background: PubMed 14710766Zucchelli G, Amore C, Sforza NM, Montebugnoli L, De Sanctis M. Bilaminar techniques for the treatment of recession-type defects. A comparative clinical study. J Clin Periodontol. 2003 Oct;30(10):862-70. doi: 10.1034/j.1600-051x.2003.00397.x.
- Background: PubMed 25644302Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.
- Background: PubMed 18454674Jung UW, Um YJ, Choi SH. Histologic observation of soft tissue acquired from maxillary tuberosity area for root coverage. J Periodontol. 2008 May;79(5):934-40. doi: 10.1902/jop.2008.070445.
- Background: PubMed 20590963Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tSCTG+ CAF and pSCTG+ CAF in people with Gingival Recession, Localized, run by Gazi 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 5 inclusion and 6 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 2 Mar 2026. 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?
The percentage of root coverage (time frame: 1-year postoperative follow-up). 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 NCT06404762, which also lists 4 linked publications.
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 2 Mar 2026.