Gingival Recession, LocalizedNCT06650072
Effectiveness of Tuberosity Micro Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects
A study testing modified coronally advanced tunnel technique combined with multiple palatal micro connective tissue grafts and modified coronally advanced tunnel technique combined with multiple tuberosity micro connective tissue grafts in people with Gingival Recession, Localized, run by Göteborg University.
Trial summary
The objective of this project is to compare post-operative pain associated with palatal and tuberosity donor sites for micro-CTG, and to evaluate the outcomes in both the donor and recipient sites. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gingival Recession, Localized
- What is being tested?
- modified coronally advanced tunnel technique combined with multiple palatal micro connective tissue grafts and modified coronally advanced tunnel technique combined with multiple tuberosity micro connective tissue grafts
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- age ≥18 years,
- systemically healthy,
- presenting adjacent RT1/RT2 recessions, on both sides of the anterior maxilla, with an apico-coronal extension (i.e. recession depth) > 2mm combined with thick phenotype and deep root concavity.
Who cannot join
- pregnancy or lactation,
- heavy tobacco smoking (>15 cigarettes/day),
- uncontrolled medical conditions and intake of medication that can affect gingival conditions.
- uncorrected trauma from toothbrushing,
- severe tooth malposition,
- history of root coverage procedures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Palatal vs Tuberosity Micro-connective Tissue Grafts for the Treatment of Multiple Adjacent Gingival Recession Defects: a Multi-center Controlled Randomized Clinical Trial
The objective of this project is to compare post-operative pain associated with palatal and tuberosity donor sites for micro-CTG, and to evaluate the outcomes in both the donor and recipient sites.
Read the detailed description
A variety of surgical methods have been reported to reestablish root coverage, including tunneling techniques and coronally and laterally advanced flaps. As thin gingival tissue is one of the predisposing factors for GRD, the adjuvant use of subepithelial connective tissue grafts (CTGs) is often considered. CTGs are thought to contribute to phenotype modification and stability of treatment outcomes and studies have indicated favorable esthetic results and high degrees of root coverage. CTGs are preferably harvested either from the lateral superficial part of the palate or from the tuberosity, due to the high amount of lamina propria and minimal submucosal tissue (adipose and glandular tissue).
When multiple adjacent teeth exhibit GRDs, the preferred surgical approach should offer the greatest possible root coverage, while limiting drawbacks (i.e., patient morbidity, esthetic problems). Thus, one of the challenges related to coverage of multiple GRDs is the scarcity of donor tissue. Modification of the harvested CTG into multiple "micro-CTG" has been proposed for the treatment of multiple adjacent GRDs (MAGRD) in order to reduce the amount of CTG to be harvested. Soft-tissue grafts from the tuberosity are increasingly gaining popularity not only because they are easier to harvest, are denser in connective tissue fibers but also because harvesting from the tuberosity presents minimal risk of intra- or post-operative complications, resulting in reduced patient morbidity. However CTG from maxillary tuberosity have been reported to induce a hyperplastic response in some patients.
The objective of this study will be to compare palatal versus tuberosity micro-CTG on postoperative pain, oral health-related quality of life (OHRQoL), degree of root coverage and esthetic outcomes.
The investigators hypothesise that no statistically significant differences will be observed in terms of %root coverage and patient satisfaction at 12 months (non-inferiority). Subjects in the test group (micro-CTG) will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to controls (superiority).
- Conditions
- Gingival Recession, Localized
- Being tested
- modified coronally advanced tunnel technique combined with multiple palatal micro connective tissue grafts, modified coronally advanced tunnel technique combined with multiple tuberosity micro connective tissue grafts
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified coronally advanced tunnel technique combined with multiple palatal micro connective tissue graftsProcedure or surgery
The connective tissue graft will be harvested from the palate.
modified coronally advanced tunnel technique combined with multiple tuberosity micro connective tissue graftsProcedure or surgery
The connective tissue graft will be harvested from the maxillary tuberosity.
| Study group | Role | What they receive |
|---|---|---|
| Palatal Micro Connective Tissue Graft | Active comparator | A mucogingival surgery where a connective tissue graft harvested from the palate is divided in multiple micro connective tissue grafts and placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects. Receives: Procedure: modified coronally advanced tunnel technique combined with multiple palatal micro connective tissue grafts |
| Tuberosity Micro Connective Tissue Graft | Experimental | A mucogingival surgery where a connective tissue graft harvested from the maxillary tuberosity is divided in multiple micro connective tissue grafts and placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects. Receives: Procedure: modified coronally advanced tunnel technique combined with multiple tuberosity micro connective tissue grafts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean mid-facial recession coverage (mRC)
Percentage of the exposed tooth root covered after surgical intervention
Measured: up to 1 year
Secondary outcomes (5)
Complete Root Coverage (CRC)
Frequency of complete root coverage
Measured: up to 1 year
Changes of Keratinized Tissue Width (KTW)
Measured as the distance from the muco-gingival-junction to the gingival margin
Measured: up to 1 year
Changes of Gingival Thickness (GT)
Measured 3 mm apically from the free gingival margin at the mid-buccal aspect of the tooth
Measured: up to 1 year
Patient Morbidity/Discomfort
Measured using an oral health-related quality of life questionnaire (OHRQoL)
Measured: up to 2 weeks
Patient Satisfaction
Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('not satisfied') and 10 ('satisfied as much as it could possibly be')
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
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 Göteborg 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Derks, DDS, PhD, Study chair, Goteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650072
- Sponsor's protocol ID
- OCarcuac-tuberosity microCTG
- Status last verified
- Mar 2025
- First submitted
- 15 Oct 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects? J Dent. 2008 Sep;36(9):659-71. doi: 10.1016/j.jdent.2008.05.007. Epub 2008 Jun 26.
PubMed 18584934Sanz-Martin I, Rojo E, Maldonado E, Stroppa G, Nart J, Sanz M. Structural and histological differences between connective tissue grafts harvested from the lateral palatal mucosa or from the tuberosity area. Clin Oral Investig. 2019 Feb;23(2):957-964. doi: 10.1007/s00784-018-2516-9. Epub 2018 Jun 18.
PubMed 29915931Dellavia C, Ricci G, Pettinari L, Allievi C, Grizzi F, Gagliano N. Human palatal and tuberosity mucosa as donor sites for ridge augmentation. Int J Periodontics Restorative Dent. 2014 Mar-Apr;34(2):179-86. doi: 10.11607/prd.1929.
PubMed 24600654Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.
PubMed 19335093
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palatal vs Tuberosity Micro-connective Tissue Grafts for the Treatment of Multiple Adjacent Gingival Recession Defects: a Multi-center Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06650072
- Acronym / sponsor ID
- OCarcuac-tuberosity microCTG
- Conditions
- Gingival Recession, Localized
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 21 Oct 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 objective of this project is to compare post-operative pain associated with palatal and tuberosity donor sites for micro-CTG, and to evaluate the outcomes in both the donor and recipient sites.
Detailed description
A variety of surgical methods have been reported to reestablish root coverage, including tunneling techniques and coronally and laterally advanced flaps. As thin gingival tissue is one of the predisposing factors for GRD, the adjuvant use of subepithelial connective tissue grafts (CTGs) is often considered. CTGs are thought to contribute to phenotype modification and stability of treatment outcomes and studies have indicated favorable esthetic results and high degrees of root coverage. CTGs are preferably harvested either from the lateral superficial part of the palate or from the tuberosity, due to the high amount of lamina propria and minimal submucosal tissue (adipose and glandular tissue).
When multiple adjacent teeth exhibit GRDs, the preferred surgical approach should offer the greatest possible root coverage, while limiting drawbacks (i.e., patient morbidity, esthetic problems). Thus, one of the challenges related to coverage of multiple GRDs is the scarcity of donor tissue. Modification of the harvested CTG into multiple "micro-CTG" has been proposed for the treatment of multiple adjacent GRDs (MAGRD) in order to reduce the amount of CTG to be harvested. Soft-tissue grafts from the tuberosity are increasingly gaining popularity not only because they are easier to harvest, are denser in connective tissue fibers but also because harvesting from the tuberosity presents minimal risk of intra- or post-operative complications, resulting in reduced patient morbidity. However CTG from maxillary tuberosity have been reported to induce a hyperplastic response in some patients.
The objective of this study will be to compare palatal versus tuberosity micro-CTG on postoperative pain, oral health-related quality of life (OHRQoL), degree of root coverage and esthetic outcomes.
The investigators hypothesise that no statistically significant differences will be observed in terms of %root coverage and patient satisfaction at 12 months (non-inferiority). Subjects in the test group (micro-CTG) will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to controls (superiority).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palatal Micro Connective Tissue Graft | Active comparator | Procedure: modified coronally advanced tunnel technique combined with multiple palatal micro connective tissue graftsA mucogingival surgery where a connective tissue graft harvested from the palate is divided in multiple micro connective tissue grafts and placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects. |
| Tuberosity Micro Connective Tissue Graft | Experimental | Procedure: modified coronally advanced tunnel technique combined with multiple tuberosity micro connective tissue graftsA mucogingival surgery where a connective tissue graft harvested from the maxillary tuberosity is divided in multiple micro connective tissue grafts and placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age ≥18 years,
- systemically healthy,
- presenting adjacent RT1/RT2 recessions, on both sides of the anterior maxilla, with an apico-coronal extension (i.e. recession depth) > 2mm combined with thick phenotype and deep root concavity.
Key exclusion criteria (6 listed)
- pregnancy or lactation,
- heavy tobacco smoking (>15 cigarettes/day),
- uncontrolled medical conditions and intake of medication that can affect gingival conditions.
- uncorrected trauma from toothbrushing,
- severe tooth malposition,
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 |
|---|---|---|
| modified coronally advanced tunnel technique combined with multiple palatal micro connective tissue graftsThe connective tissue graft will be harvested from the palate. | Procedure or surgery | Palatal Micro Connective Tissue Graft |
| modified coronally advanced tunnel technique combined with multiple tuberosity micro connective tissue graftsThe connective tissue graft will be harvested from the maxillary tuberosity. | Procedure or surgery | Tuberosity Micro Connective Tissue Graft |
Primary outcome
Mean mid-facial recession coverage (mRC)
Time frame: up to 1 year
Percentage of the exposed tooth root covered after surgical intervention
5 secondary outcomes
Complete Root Coverage (CRC)
Time frame: up to 1 year
Changes of Keratinized Tissue Width (KTW)
Time frame: up to 1 year
Changes of Gingival Thickness (GT)
Time frame: up to 1 year
Patient Morbidity/Discomfort
Time frame: up to 2 weeks
Patient Satisfaction
Time frame: up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Results publication: PubMed 18584934Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects? J Dent. 2008 Sep;36(9):659-71. doi: 10.1016/j.jdent.2008.05.007. Epub 2008 Jun 26.
- Results publication: PubMed 29915931Sanz-Martin I, Rojo E, Maldonado E, Stroppa G, Nart J, Sanz M. Structural and histological differences between connective tissue grafts harvested from the lateral palatal mucosa or from the tuberosity area. Clin Oral Investig. 2019 Feb;23(2):957-964. doi: 10.1007/s00784-018-2516-9. Epub 2018 Jun 18.
- Results publication: PubMed 24600654Dellavia C, Ricci G, Pettinari L, Allievi C, Grizzi F, Gagliano N. Human palatal and tuberosity mucosa as donor sites for ridge augmentation. Int J Periodontics Restorative Dent. 2014 Mar-Apr;34(2):179-86. doi: 10.11607/prd.1929.
- Results publication: PubMed 19335093Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.
- 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.
Jan Derks, DDS, PhD study chair
Goteborg University
Questions about this trial
What is this clinical trial studying?
A study testing modified coronally advanced tunnel technique combined with multiple palatal micro connective tissue grafts and modified coronally advanced tunnel technique combined with multiple tuberosity micro connective tissue grafts in people with Gingival Recession, Localized, run by Göteborg University.
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 3 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: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier Carcuac, DDS, PhD (556275575 ext. 00971, olivier.carcuac@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean mid-facial recession coverage (mRC) (time frame: up to 1 year). 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 NCT06650072, 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 12 Mar 2025.