Root Coverage for Gingival Recessions: a Randomized Clinical Trial Using Coronally Advanced Tunnel Technique and Novomatrix®

NCT06719648 | Completed

• 1 other identifier: PER-ECL-2019-07
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized clinical trial comparing the modified tunnel technique with the use of acellular xenogeneic matrix and connective tissue with the use leucocyte platlet rich fibrin (L-PRF)

Conditions

L-PRF; Surgery

Outcome Measures

Primary Outcomes (1)

• Mean root coverage

  amount of root surface covered by healthy gum tissue

  Baseline, 6 and 12 months

Secondary Outcomes (1)

• Complete root coverage

  Baseline, 6 and 12 months

Study Arms (2)

Novomatrix and LPRF

EXPERIMENTAL

Incisions: Incisions were made in the gums using a specialized scalpel. Flap Elevation: The gum tissue was lifted away from the underlying bone using a dental elevator. Partial Thickness Dissection: The tissue was cut to release tension and allow for easier repositioning. Interdental Papilla Elevation: The gum tissue between the teeth was partially lifted. Flap Extension: The flap was extended to cover more teeth for better coverage. Tissue Separation: The flap was carefully separated from underlying tissues to allow for proper positioning. Root Preparation: The exposed root surfaces were smoothed and cleaned.

Device: Acellular dermal matrix + L-Prf

Connective tissue graft and LPRF

ACTIVE COMPARATOR

Incisions: Incisions were made in the gums using a specialized scalpel. Flap Elevation: The gum tissue was lifted away from the underlying bone using a dental elevator. Partial Thickness Dissection: The tissue was cut to release tension and allow for easier repositioning. Interdental Papilla Elevation: The gum tissue between the teeth was partially lifted. Flap Extension: The flap was extended to cover more teeth for better coverage. Tissue Separation: The flap was carefully separated from underlying tissues to allow for proper positioning. Root Preparation: The exposed root surfaces were smoothed and cleaned.

Procedure: Connective Tissue graft + L-Prf

Interventions

Acellular dermal matrix + L-Prf DEVICE

Incisions: Incisions were made in the gums using a specialized scalpel. Flap Elevation: The gum tissue was lifted away from the underlying bone using a dental elevator. Partial Thickness Dissection: The tissue was cut to release tension and allow for easier repositioning. Interdental Papilla Elevation: The gum tissue between the teeth was partially lifted. Flap Extension: The flap was extended to cover more teeth for better coverage. Tissue Separation: The flap was carefully separated from underlying tissues to allow for proper positioning. Root Preparation: The exposed root surfaces were smoothed and cleaned.

Novomatrix and LPRF

Connective Tissue graft + L-Prf PROCEDURE

Incisions: Incisions were made in the gums using a specialized scalpel. Flap Elevation: The gum tissue was lifted away from the underlying bone using a dental elevator. Partial Thickness Dissection: The tissue was cut to release tension and allow for easier repositioning. Interdental Papilla Elevation: The gum tissue between the teeth was partially lifted. Flap Extension: The flap was extended to cover more teeth for better coverage. Tissue Separation: The flap was carefully separated from underlying tissues to allow for proper positioning. Root Preparation: The exposed root surfaces were smoothed and cleaned.

Connective tissue graft and LPRF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Presence of 2 or more adjacent Cairo's type I or II gingival recessions
• Non-smokers
• Plaque index \<20% and bleeding on probing (BOP) \<20%
• Periodontal health
• Existing endodontic therapies must be carefully evaluated. In case of inadequate treatments, endodontic retreatment will be performed (i.e., a minimum of two months before performing the surgical therapy).
• Use of optical magnification (2.5X) and microsurgical instruments for the surgical procedure is recommended.

You may not qualify if:

• Systemic compromise involving healing response and tissue repair, or coagulation disorders
• Uncontrolled systemic diseases
• Use of anticoagulant therapy or bisphosphonates
• Active periodontal disease
• Inadequate psychological profile
• Patients with intentions to change residence that would prevent follow-up
• Multiple recessions in molars

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Isabel Arroyo

Barcelona, Barcelona, 08037, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontist

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: December 6, 2024
• Study Start: May 20, 2020
• Primary Completion: April 27, 2023
• Study Completion: April 28, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

ES (1)