Effectiveness of Tuberosity Micro Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects

NCT06650072 | Not Yet Recruiting

• 1 other identifier: OCarcuac-tuberosity microCTG
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gingival Recession, Localized

Outcome Measures

Primary Outcomes (1)

• Mean mid-facial recession coverage (mRC)

  Percentage of the exposed tooth root covered after surgical intervention

  up to 1 year

Secondary Outcomes (5)

• Complete Root Coverage (CRC)

  up to 1 year

• Changes of Keratinized Tissue Width (KTW)

  up to 1 year

• Changes of Gingival Thickness (GT)

  up to 1 year

• Patient Morbidity/Discomfort

  up to 2 weeks

• Patient Satisfaction

  up to 1 year

Study Arms (2)

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.

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.

Procedure: modified coronally advanced tunnel technique combined with multiple tuberosity micro connective tissue grafts

Interventions

modified coronally advanced tunnel technique combined with multiple palatal micro connective tissue grafts PROCEDURE

The connective tissue graft will be harvested from the palate.

Palatal Micro Connective Tissue Graft

modified coronally advanced tunnel technique combined with multiple tuberosity micro connective tissue grafts PROCEDURE

The connective tissue graft will be harvested from the maxillary tuberosity.

Tuberosity Micro Connective Tissue Graft

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead

Related Publications (4)

• 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.

  PMID: 18584934 RESULT

• Sanz-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.

  PMID: 29915931 RESULT

• Dellavia 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.

  PMID: 24600654 RESULT

• 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: 19335093 RESULT

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Jan Derks, DDS, PhD

  Goteborg University

  STUDY CHAIR

Central Study Contacts

Olivier Carcuac, DDS, PhD

CONTACT

556275575; olivier.carcuac@gu.se

Jan Derks, DDS, PhD

CONTACT

317863124; jan.derks@odontologi.gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 21, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share