AzTrials
AzTrials

Gingival RecessionNCT07590960

Modified Coronally Advanced Tunnel for Mandibular Lingual Root Coverage

A study testing Modified Coronally Advanced Tunnel with Connective Tissue Graft in people with Gingival Recession and Mucogingival Deformity - Insufficient Keratinized Tissue, run by University of Pittsburgh at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

This study will follow adults who have gum recession on the tongue side of the lower teeth. Participants will receive a gum surgery called the Modified Coronally Advanced Tunnel technique with a connective tissue graft taken from the roof of the mouth. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Modified Coronally Advanced Tunnel with Connective Tissue Graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
23 Jul 2026to Dec 2028
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-65 years
  • Single or multiple Cairo RT1 lingual gingival recessions ≥3 mm on mandibular incisors, canines, or premolars
  • Identifiable CEJ on the lingual aspect
  • Vital uniradicular teeth
  • Full-mouth plaque score <20%
  • Smokes less than 10 cigarettes per day
  • Adequate mouth opening for lingual access
  • Sufficient palatal donor tissue thickness (≥2 mm at 2-3 mm from gingival margin)

Who cannot join

  • Positive urine pregnancy test or self-reported lactation
  • Smoker more than 10 cigarettes per day
  • Uncontrolled systemic diseases, at the discretion of the PI (diabetes HbA1c >7%, cardiovascular disease, immunocompromised)
  • Use of medications affecting periodontal tissues (phenytoin, calcium channel blockers, immunosuppressants)
  • Use of blood thinners
  • Previous root coverage surgery at treated sites
Show all 9Show fewer
  • Teeth with cervical restorations or caries on lingual surfaces
  • Inadequate attached gingiva (<1 mm)
  • Prominent lingual frenum attachment requiring frenectomy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • University of Pittsburgh School of Dental Medicine

    Pittsburgh, Pennsylvania, 15261

Other trials in United States

About this study

Official title: Clinical Outcomes of Modified Coronally Advanced Tunnel Technique With Deepithelialized Connective Tissue Graft for Mandibular Lingual Root Coverage: A Case Series

This study will follow adults who have gum recession on the tongue side of the lower teeth. Participants will receive a gum surgery called the Modified Coronally Advanced Tunnel technique with a connective tissue graft taken from the roof of the mouth. The study will include 20 participants and will follow them for up to 24 months after surgery. The main outcome is how much of the exposed root is covered 6 months after surgery. The study will also measure gum thickness, gum width, tooth sensitivity, healing, patient comfort, satisfaction, and three-dimensional soft tissue changes using intraoral scans.

Read the detailed description

This is a single-site prospective case series at the University of Pittsburgh School of Dental Medicine. Adults with single or multiple Cairo RT1 lingual gingival recessions of at least 3 mm on mandibular incisors, canines, or premolars will be enrolled if they meet the study eligibility criteria.

All participants will receive the same surgical treatment. During the procedure, the surgeon will create a tunnel under the gum tissue on the tongue side of the affected lower tooth or teeth. A small piece of tissue will be taken from the palate, prepared as a connective tissue graft, placed under the gum tissue, and stabilized with sutures to help cover the exposed root surface.

Participants will have study visits before surgery, on the day of surgery, during early healing, and at scheduled follow-up visits through 24 months after surgery. The primary outcome will be assessed at 6 months after surgery.

At follow-up visits, the study team will collect gum measurements, assess tooth sensitivity, record healing or post-operative complications, and collect patient-reported outcomes about pain, discomfort, function, appearance, and satisfaction. Intraoral photographs and intraoral scans will also be collected to document healing and measure three-dimensional soft tissue changes over time.

Being tested
Modified Coronally Advanced Tunnel with Connective Tissue Graft
Keywords
Gingival Recession, Tissue Grafts, Tooth Sensitivity
Medical subject headings
Gingival Recession, Dentin Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified Coronally Advanced Tunnel with Connective Tissue GraftProcedure or surgery

    The procedure consists of lingual tunnel preparation without vertical releasing incisions, followed by placement of a deepithelialized connective tissue graft harvested from the palate. Root surface conditioning may be performed with EDTA gel before graft placement. The graft is positioned to cover the exposed root surface, and the lingual flap is advanced coronally and secured with sutures to achieve stable, tension-free coverage.

Study groups in NCT07590960
Study groupRoleWhat they receive
Modified Coronally Advanced Tunnel with Connective Tissue GraftExperimentalAdults with single or multiple Cairo RT1 mandibular lingual gingival recessions of at least 3 mm on mandibular incisors, canines, or premolars who will receive standardized Modified Coronally Advanced Tunnel surgery with a deepithelialized connective tissue graft and will be followed for up to 24 months.
Receives: Procedure: Modified Coronally Advanced Tunnel with Connective Tissue Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change in Root Coverage from Baseline at 6 Months

    Mean root coverage will be calculated as baseline recession depth minus recession depth at 6 months post-surgery. Recession depth will be measured in millimeters from the cementoenamel junction to the gingival margin at the mid-lingual aspect using a UNC-15 periodontal probe by a calibrated examiner blinded to baseline measurements

    Measured: Baseline and 6 months post-surgery.

Secondary outcomes (19)

  1. Percentage Root Coverage at 6 Months

    Percentage root coverage will be calculated as [(baseline recession depth minus 6-month recession depth) / baseline recession depth] × 100. Additional measurements will be collected at 3, 12, 15, 18, 21, and 24 months post-surgery for descriptive analyses.

    Measured: 6 months post-surgery

  2. Frequency of Complete Root Coverage at 6 Months

    Recession depth will be measured in millimeters from the cementoenamel junction to the gingival margin at the mid-lingual aspect using a UNC-15 periodontal probe.

    Measured: 6 months post-surgery

  3. Change from Baseline in Recession Depth at 6 Months

    Recession depth will be measured from the cementoenamel junction to the gingival margin at the mid-lingual aspect using a UNC-15 periodontal probe.

    Measured: Baseline and 6 months post-surgery

  4. Change from Baseline in Recession Width at 6 Months

    Recession width will be measured as the mesiodistal width of the recession defect at the cementoenamel junction level.

    Measured: Baseline and 6 months post-surgery

  5. Change from Baseline in Clinical Attachment Level at 6 Months

    Clinical attachment level will be measured from the cementoenamel junction to the base of the sulcus at the treated lingual site using a UNC-15 periodontal probe.

    Measured: Baseline and 6 months post-surgery

  6. Change from Baseline in Probing Depth at 6 Months

    Probing depth will be measured from the gingival margin to the base of the sulcus at the treated lingual site using a UNC-15 periodontal probe.

    Measured: Baseline and 6 months post-surgery

  7. Change from Baseline in Keratinized Tissue Width at 6 Months

    Keratinized tissue width will be measured from the gingival margin to the mucogingival junction using a UNC-15 periodontal probe.

    Measured: Baseline and 6 months post-surgery

  8. Change from Baseline in Gingival Thickness at 6 Months

    Gingival thickness will be measured 2 mm apical to the gingival margin using a #15 endodontic file with a rubber stop under local anesthesia.

    Measured: Baseline and 6 months post-surgery

  9. Surgical time (minutes)

    Surgical time will be recorded in minutes from incision to final suture.

    Measured: Day of surgery

  10. Number of Participants with Early Post-operative Complications Within 2 Weeks

    Early complications will include graft exposure, wound dehiscence, infection, bleeding, or other post-operative complications documented during early healing.

    Measured: Up to 2 weeks post-surgery

  11. Post-operative Pain Score on Visual Analog Scale at Day 7

    Post-operative pain will be assessed using a 100-millimeter visual analog scale, where 0 represents no pain and 100 represents extreme pain. Additional pain assessments will be collected on Days 1 and 3 post-surgery for descriptive analyses.

    Measured: Day 7 post-surgery

  12. Functional Impairment Score on Visual Analog Scale at Day 7

    Functional impairment related to speaking, swallowing, or eating will be assessed using a 100-millimeter visual analog scale, where 0 represents no impairment and 100 represents extreme impairment. Additional assessments will be collected on Days 1 and 3 post-surgery for descriptive analyses.

    Measured: Day 7 post-surgery

  13. Aesthetic Satisfaction Score on Visual Analog Scale at 6 Months

    Patient satisfaction with the appearance of the treated area will be assessed using a 100-millimeter visual analog scale, where 0 represents extremely unsatisfied and 100 represents extremely satisfied. Additional assessments will be collected at 12 and 24 months post-surgery for descriptive analyses.

    Measured: 6 months post-surgery

  14. Overall Treatment Satisfaction Score on Visual Analog Scale at 6 Months

    Overall satisfaction with the treatment outcome will be assessed using a 100-millimeter visual analog scale, where 0 represents extremely unsatisfied and 100 represents extremely satisfied. Additional assessments will be collected at 12 and 24 months post-surgery for descriptive analyses.

    Measured: 6 months post-surgery

  15. Willingness to undergo the procedure again (VAS 0-100 mm; higher score = better outcome)

    Participants will rate their willingness to undergo the procedure again using a 100-mm visual analog scale, where 0 represents would not undergo the procedure again and 100 represents definitely would undergo the procedure again.

    Measured: 24 months post-surgery

  16. Change from Baseline in Root Hypersensitivity Score on Visual Analog Scale at 6 Months

    Root hypersensitivity will be assessed using a 100-millimeter visual analog scale after an air blast test, where higher scores indicate greater hypersensitivity. Additional assessments will be collected at 12 and 24 months post-surgery for descriptive analyses.

    Measured: Baseline and 6 months post-surgery

  17. Three-Dimensional Soft Tissue Volume Change at 6 Months

    Soft tissue volume change will be assessed using intraoral scans exported as STL files. Baseline and 6-month scans will be superimposed, and the absolute volumetric difference within a standardized region of interest will be calculated in cubic millimeters. Additional scans will be collected at 3, 12, and 24 months post-surgery for descriptive analyses.

    Measured: Baseline and 6 months post-surgery

  18. Mean Soft Tissue Thickness Change from Intraoral Scans at 6 Months

    Mean tissue thickness change will be calculated as the average perpendicular distance between superimposed baseline and 6-month intraoral scan surfaces within the defined region of interest. Additional scans will be collected at 3, 12, and 24 months post-surgery for descriptive analyses.

    Measured: Baseline and 6 months post-surgery

  19. Long-term Stability of Root Coverage at 24 Months

    Long-term stability will be measured as the change in recession depth from baseline to 24 months post-surgery, expressed in millimeters. This outcome assesses whether the root coverage achieved at the 6-month primary endpoint is maintained over the extended follow-up period.

    Measured: Baseline and 24 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2026
  2. Study start23 Jul 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
Prospective single-arm case series. All enrolled participants undergo the same surgical intervention (Modified Coronally Advanced Tunnel technique with deepithelialized connective tissue graft) for treatment of mandibular lingual gingival recessions.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07590960
Sponsor's protocol ID
STUDY26020003
Status last verified
Jul 2026
First submitted
1 May 2026
Last updated
29 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.

    PubMed 21507033

  • Cairo 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

  • Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009 Feb;80(2):244-52. doi: 10.1902/jop.2009.080253.

    PubMed 19186964

  • Tavelli L, Barootchi S, Nguyen TVN, Tattan M, Ravida A, Wang HL. Efficacy of tunnel technique in the treatment of localized and multiple gingival recessions: A systematic review and meta-analysis. J Periodontol. 2018 Sep;89(9):1075-1090. doi: 10.1002/JPER.18-0066. Epub 2018 Aug 13.

    PubMed 29761502

  • Chambrone 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 25644302

  • Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.

    PubMed 24640997

  • Jepsen S, Caton JG, Albandar JM, Bissada NF, Bouchard P, Cortellini P, Demirel K, de Sanctis M, Ercoli C, Fan J, Geurs NC, Hughes FJ, Jin L, Kantarci A, Lalla E, Madianos PN, Matthews D, McGuire MK, Mills MP, Preshaw PM, Reynolds MA, Sculean A, Susin C, West NX, Yamazaki K. Periodontal manifestations of systemic diseases and developmental and acquired conditions: Consensus report of workgroup 3 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S237-S248. doi: 10.1002/JPER.17-0733.

    PubMed 29926943

  • Scheyer ET, Sanz M, Dibart S, Greenwell H, John V, Kim DM, Langer L, Neiva R, Rasperini G. Periodontal soft tissue non-root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S73-6. doi: 10.1902/jop.2015.140377.

    PubMed 25644301

  • Cortellini P, Bissada NF. Mucogingival conditions in the natural dentition: Narrative review, case definitions, and diagnostic considerations. J Periodontol. 2018 Jun;89 Suppl 1:S204-S213. doi: 10.1002/JPER.16-0671.

    PubMed 29926948

  • Barootchi S, Tavelli L, Zucchelli G, Giannobile WV, Wang HL. Gingival phenotype modification therapies on natural teeth: A network meta-analysis. J Periodontol. 2020 Nov;91(11):1386-1399. doi: 10.1002/JPER.19-0715. Epub 2020 Jun 12.

    PubMed 32392401

  • Assis G, Nevins M, Kim DM. The Use of Autogenous Gingival Graft for Treatment of Lingual Recession on Mandibular Anterior Teeth. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):667-671. doi: 10.11607/prd.3263.

    PubMed 28817130

  • Soileau KM. Treatment of a mucogingival defect associated with intraoral piercing. J Am Dent Assoc. 2005 Apr;136(4):490-4. doi: 10.14219/jada.archive.2005.0205.

    PubMed 15884319

  • Wilcko MT, Wilcko WM, Murphy KG, Carroll WJ, Ferguson DJ, Miley DD, Bouquot JE. Full-thickness flap/subepithelial connective tissue grafting with intramarrow penetrations: three case reports of lingual root coverage. Int J Periodontics Restorative Dent. 2005 Dec;25(6):561-9.

    PubMed 16353531

  • Zucchelli G, Bentivogli V, Ganz S, Bellone P, Mazzotti C. The connective tissue graft wall technique to improve root coverage and clinical attachment levels in lingual gingival defects. Int J Esthet Dent. 2016;11(4):538-548.

    PubMed 27730223

  • Mehrotra VK, Triveni MG, Tarun Kumar AB, Chandra RV. Minimally invasive treatment of mandibular anterior lingual defects by vestibular incision subperiosteal tunnel access technique and connective tissue graft: a case report. Clin Adv Periodontics. 2017;7(4):195-200.

Questions about this trial

What is this clinical trial studying?

A study testing Modified Coronally Advanced Tunnel with Connective Tissue Graft in people with Gingival Recession and Mucogingival Deformity - Insufficient Keratinized Tissue, run by University of Pittsburgh at 1 site in United States.

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 8 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 29 Jul 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 United States. 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?

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?

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?

Mean Change in Root Coverage from Baseline at 6 Months (time frame: Baseline and 6 months post-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 NCT07590960, which also lists 17 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 29 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in