Root Coverage With Tunneling Technique With Connective Tissue Versus Coronal Advancement Flap Technique.

NCT06228534 | Completed Early Phase 1 DMC

• 1 other identifier: TUN/CAF25/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized triple-blind clinical trial. This comparative clinical study investigates the efficacy of root coverage using two periodontal techniques: the tunneling technique and the coronal advancement technique. The objective is to evaluate and compare the clinical, esthetic and patient perception outcomes after undergoing each procedure. Participants with specific gingival recessions will be included, and follow-up will be performed to measure root coverage, keratinized tissue gain and other relevant parameters. In addition, a detailed analysis of the morbidity associated with each technique will be performed. This study aims to provide valuable information to guide oral health professionals in choosing the most appropriate technique for the treatment of gingival recessions.

Conditions

Gingival Recession, Localized; Gingival Recession

Keywords

Root coverage; randomized clinical trial; connective tissue graft; coronally advanced flap

Outcome Measures

Primary Outcomes (4)

• tunneling technique

  Periodontal status and smoking habits (% of bleeding and bacterial plaque) Type ode recesión (I o II) Recession location (upper and lower jaw) Preoperative preparation Treatment in the intervention group Post-surgical treatment Suture time mRC ± SD (%) (recubrimiento radicular) Aesthetic Root Cover Score (RES) percentage of root coverage (RC, %) and percentage of defects with complete root coverage (CRC, %)

  A 3 month follow-up

• coronal advancement flap technique

  Periodontal status and smoking habits (% of bleeding and bacterial plaque) Type ode recesión (I o II) Recession location (upper and lower jaw) Preoperative preparation Treatment in the control group Post-surgical treatment Suture time Follow-up (months) mRC ± SD (%) (recubrimiento radicular) Aesthetic Root Cover Score (RES) percentage of root coverage (RC, %) and percentage of defects with complete root coverage (CRC, %)

  A 3 month follow-up

• tunneling technique

  Periodontal status and smoking habits (% of bleeding and bacterial plaque) Type ode recesión (I o II) Recession location (upper and lower jaw) Preoperative preparation Treatment in the intervention group Post-surgical treatment Suture time mRC ± SD (%) (recubrimiento radicular) Aesthetic Root Cover Score (RES) percentage of root coverage (RC, %) and percentage of defects with complete root coverage (CRC, %)

  A 6 month follow-up

• coronal advancement flap technique

  Periodontal status and smoking habits (% of bleeding and bacterial plaque) Type ode recesión (I o II) Recession location (upper and lower jaw) Preoperative preparation Treatment in the intervention group Post-surgical treatment Suture time mRC ± SD (%) (recubrimiento radicular) Aesthetic Root Cover Score (RES) percentage of root coverage (RC, %) and percentage of defects with complete root coverage (CRC, %)

  A 6 month follow-up

Secondary Outcomes (2)

• tunneling technique

  A 3 - 6 month follow-up

• coronal advancement flap technique

  A 3 - 6 month follow-up

Study Arms (2)

tunneling technique with connective tissue

EXPERIMENTAL

GRUPO TEST: THE RECIPIENT BED OF THE CONNECTIVE GRAFT, THE TUNNELING TECHNIQUE IS PREPARED.

Procedure: Root coverage with tunneling technique

coronal advancement flap technique

EXPERIMENTAL

GRUPO CONTROL: THE RECIPIENT BED OF THE CONNECTIVE GRAFT, THE CORONAL ADVANCEMENT FLAP TECHNIQUE IS PREPARED

Procedure: Root coverage with tunneling technique

Interventions

Root coverage with tunneling technique PROCEDURE

THIS IS THE INTERVENTION GROUP THE RECIPIENT AREA OF THE CONNECTIVE GRAFT IS PREPARED.

Also known as: Root coverage

coronal advancement flap technique; tunneling technique with connective tissue

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoking
• No systemic diseases, no pregnancy
• No active periodontal disease
• Bacterial plaque and bleeding Score ≤9%.
• No medication that interferes with periodontal tissue health or scarring.
• Teeth without root canal treatments
• No contraindication to periodontal surgery
• Presence of at least one type I and II Miller O RT1 - RT2 recession defect with at least 4 recessions in the upper or lower jaw that clearly shows the amelocementary limit.
• Work will be done on upper central incisors, upper lateral incisors, upper canines and upper premolars.
• For the coronal advancement technique, multiple or unitary gingival recessions will be used

You may not qualify if:

• SMOKING PATIENT
• PATIENT WITH A SYSTEMIC DISEASE
• WITH PERIODONTAL DISEASE
• GINGIVAL RECESSION CLASS III OR RT3
• PATIENT WITH EDENTULISM
• PATIENT WITHOUT AMELOCEMENTARY LIMIT

Sponsors & Collaborators

• Luis Alberto Chauca Bajaña: lead
• Universidad de Guayaquil: collaborator

Study Sites (1)

Private clinic

Guayaquil, Guayas, 090101, Ecuador

Location

Related Publications (4)

• Azaripour A, Kissinger M, Farina VS, Van Noorden CJ, Gerhold-Ay A, Willershausen B, Cortellini P. Root coverage with connective tissue graft associated with coronally advanced flap or tunnel technique: a randomized, double-blind, mono-centre clinical trial. J Clin Periodontol. 2016 Dec;43(12):1142-1150. doi: 10.1111/jcpe.12627. Epub 2016 Oct 25.

  PMID: 27716979 BACKGROUND

• Tavelli L, Majzoub J, Kauffmann F, Rodriguez MV, Mancini L, Chan HL, Kripfgans OD, Giannobile WV, Wang HL, Barootchi S. Coronally advanced flap versus tunnel technique for the treatment of peri-implant soft tissue dehiscences with the connective tissue graft: A randomized, controlled clinical trial. J Clin Periodontol. 2023 Jul;50(7):980-995. doi: 10.1111/jcpe.13806. Epub 2023 Apr 4.

  PMID: 36935199 BACKGROUND

• Gonzalez-Febles J, Romandini M, Laciar-Oudshoorn F, Noguerol F, Marruganti C, Bujaldon-Daza A, Zabalegui I, Sanz M. Tunnel vs. coronally advanced flap in combination with a connective tissue graft for the treatment of multiple gingival recessions: a multi-center randomized clinical trial. Clin Oral Investig. 2023 Jul;27(7):3627-3638. doi: 10.1007/s00784-023-04975-7. Epub 2023 Mar 29.

  PMID: 36988824 BACKGROUND

• Chauca-Bajana L, Vasquez Gonzalez PS, Alban Guijarro MJ, Guim Martinez CA, Velasquez Ron B, Proano Yela P, Lorenzo-Pouso AI, Perez-Jardon A, Ordonez Balladares A. Comparative Effectiveness of Tunneling vs. Coronally Advanced Flap Techniques for Root Coverage: A 6-12-Month Randomized Clinical Trial. Bioengineering (Basel). 2025 Jul 30;12(8):824. doi: 10.3390/bioengineering12080824.

  PMID: 40868339 DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• LUIS CHAUCA, PHD (C)

  Universidad de Guayaquil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: specialist in periodontics and surgical implantology, master in research, PHD (C)

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: January 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: June 20, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: From the beginning to sex month after finishing the study
• Access Criteria: Under request

Locations

EC (1)