NCT07590960

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
31mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Dec 2028

First Submitted

Initial submission to the registry

May 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 1, 2026

Last Update Submit

May 17, 2026

Conditions

Keywords

Gingival RecessionTissue GraftsTooth Sensitivity

Outcome Measures

Primary Outcomes (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

    Baseline and 6 months post-surgery.

Secondary Outcomes (19)

  • Percentage Root Coverage at 6 Months

    6 months post-surgery

  • Frequency of Complete Root Coverage at 6 Months

    6 months post-surgery

  • Change from Baseline in Recession Depth at 6 Months

    Baseline and 6 months post-surgery

  • Change from Baseline in Recession Width at 6 Months

    Baseline and 6 months post-surgery

  • Change from Baseline in Clinical Attachment Level at 6 Months

    Baseline and 6 months post-surgery

  • +14 more secondary outcomes

Study Arms (1)

Modified Coronally Advanced Tunnel with Connective Tissue Graft

EXPERIMENTAL

Adults 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.

Procedure: Modified Coronally Advanced Tunnel with Connective Tissue Graft

Interventions

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.

Modified Coronally Advanced Tunnel with Connective Tissue Graft

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • Teeth with cervical restorations or caries on lingual surfaces
  • Inadequate attached gingiva (\<1 mm)
  • Prominent lingual frenum attachment requiring frenectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh School of Dental Medicine

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (17)

  • 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.

    PMID: 21507033BACKGROUND
  • 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.

    PMID: 19335093BACKGROUND
  • 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.

    PMID: 19186964BACKGROUND
  • 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.

    PMID: 29761502BACKGROUND
  • 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.

    PMID: 25644302BACKGROUND
  • 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.

    PMID: 24640997BACKGROUND
  • 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.

    PMID: 29926943BACKGROUND
  • 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.

    PMID: 25644301BACKGROUND
  • 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.

    PMID: 29926948BACKGROUND
  • 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.

    PMID: 32392401BACKGROUND
  • 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.

    PMID: 28817130BACKGROUND
  • 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.

    PMID: 15884319BACKGROUND
  • 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.

    PMID: 16353531BACKGROUND
  • 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.

    PMID: 27730223BACKGROUND
  • 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.

    BACKGROUND
  • Alves JP, Marques TM, Malta Santos NB, Correia Sousa M, Coutinho Alves C, Correia AR. Lingual Incision Subperiosteal Tunnel Access: Proof of Concept 18-Month Follow-Up. Clin Adv Periodontics. 2019 Dec;9(4):196-202. doi: 10.1002/cap.10072. Epub 2019 Sep 26.

    PMID: 31507099BACKGROUND
  • Yadav VS, Kamra P, Singh N, Chandra RV. Treatment of multiple lingual gingival recession defects in mandibular incisors with modified coronally advanced tunnel technique. Contemp Clin Dent. 2018;9(Suppl 2):S345-9.

    BACKGROUND

MeSH Terms

Conditions

Gingival RecessionDentin Sensitivity

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal AtrophyTooth Diseases

Study Officials

  • Andrea Ravida, DDS, MS, PhD

    University of Pittsburgh, Department of Periodontics and Preventive Dentistry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Ravida, DDS, MS, PhD

CONTACT

Carla Sanchez, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
A calibrated examiner, blinded to baseline measurements, will perform all post-operative clinical assessments to minimize measurement bias.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 15, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations