Comparing Two Different Tunneling Technique for Gingival Recession Treatment Using Two Different Matertial

NCT06065774 | Completed DMC

• 1 other identifier: A04060722
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare two different tunneling surgical technique in treatment of gingival recession using two different materials. Participants will be divided into four groups according to the treatments they'll be given.

Conditions

Gingival Recession, Localized

Keywords

gingival recession; laterally closed tunnel; modified coronally advanced tunnel; porcine derived collagen matrix; isolated gingival recession; tunneling technique

Outcome Measures

Primary Outcomes (1)

• Gingival Recession Depth (RD)

  measured as the distance from the CEJ to the gingival margin.

  6 months

Secondary Outcomes (10)

• Complete Root Coverage (CRC)

  6 months

• Mean Root Coverage (MRC)

  6 months

• Gingival Biotype Thickness

  6 months

• Apico-coronal Width of Keratinized Tissue (KTW)

  6 months

• Root coverage Esthetic Score (RES)

  6 months

Study Arms (4)

The Laterally Closed Tunnel Technique with SCTG

EXPERIMENTAL

An aseptic field was required for all surgical procedures using povidine iodine. Local anesthesia using 4% articane with 1:100.000 epinephrine was applied.• * Then specially designed tunneling instruments \[devmed\] were used through the sulcular incision to create a pouch. * A microsurgical blade was used at the inner surface of the pouch till sufficient tissue release was achieved. * Tissue forceps was used to approximate the mesial and distal margin of the gingiva at the pouch margin. * After harvesting the graft, it was placed at the prepared pouch after root surface biomodification using EDTA gel 24% for 2 minutes and copious rinsing with saline solution. * SCTG was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material \[Vicryl suture\], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.

Procedure: The Laterally Closed Tunnel Technique with SCTG; Drug: The Laterally Closed Tunnel Technique with collagen matrix mucograft; Procedure: Modified Coronally Advanced Tunnel Technique with SCTG.; Drug: Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft

The Laterally Closed Tunnel Technique with collagen matrix mucograft

EXPERIMENTAL

An aseptic field was required for all surgical procedures using povidine iodine. Local anesthesia using 4% articane with 1:100.000 epinephrine was applied.• * Then specially designed tunneling instruments \[devmed\] were used through the sulcular incision to create a pouch. * A microsurgical blade was used at the inner surface of the pouch till sufficient tissue release was achieved. * Tissue forceps was used to approximate the mesial and distal margin of the gingiva at the pouch margin. * After harvesting the graft, it was placed at the prepared pouch after root surface biomodification using EDTA gel 24% for 2 minutes and copious rinsing with saline solution. * collagen matrix was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material \[Vicryl suture\], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.

Procedure: The Laterally Closed Tunnel Technique with SCTG; Drug: The Laterally Closed Tunnel Technique with collagen matrix mucograft; Procedure: Modified Coronally Advanced Tunnel Technique with SCTG.; Drug: Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft

Modified Coronally Advanced Tunnel Technique with SCTG.

EXPERIMENTAL

* Supraperiosteal incisions was extended to the mucosal level beyond the MGJ to allow sufficient tissue mobility and release. * The tunnel was extended in all directions around the recession defect to create a sufficient pouch for connective tissue graft stabilization. * The interdental papilla tunneling adjacent to the defect was a critical step for technique success. * Then perfect root planning was performed at the denuded root surface to remove the necrotic cementum at the accessible recession defect. * Subsequently palatal anesthesia was given to harvest palatal SCTG using deepitheliailized free gingival graft (FGG) technique. * SCTG was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material \[Vicryl suture\], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.

Procedure: The Laterally Closed Tunnel Technique with SCTG; Drug: The Laterally Closed Tunnel Technique with collagen matrix mucograft; Procedure: Modified Coronally Advanced Tunnel Technique with SCTG.; Drug: Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft

Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft

EXPERIMENTAL

* Supraperiosteal incisions was extended to the mucosal level beyond the MGJ to allow sufficient tissue mobility and release. * The tunnel was extended in all directions around the recession defect to create a sufficient pouch for connective tissue graft stabilization. * The interdental papilla tunneling adjacent to the defect was a critical step for technique success. * Then perfect root planning was performed at the denuded root surface to remove the necrotic cementum at the accessible recession defect. * Subsequently palatal anesthesia was given to harvest palatal SCTG using deepitheliailized free gingival graft (FGG) technique. * collagen matrix was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material \[Vicryl suture\], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.

Procedure: The Laterally Closed Tunnel Technique with SCTG; Drug: The Laterally Closed Tunnel Technique with collagen matrix mucograft; Procedure: Modified Coronally Advanced Tunnel Technique with SCTG.; Drug: Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft

Interventions

The Laterally Closed Tunnel Technique with SCTG PROCEDURE

Local anesthesia using 4% articane with 1:100.000 epinephrine was applied.• Then specially designed tunneling instruments \[devmed\] were used through the sulcular incision to create a pouch. A microsurgical blade was used at the inner surface of the pouch till sufficient tissue release was achieved. Tissue forceps was used to approximate the mesial and distal margin of the gingiva at the pouch margin. After harvesting the graft, it was placed at the prepared pouch after root surface biomodification using EDTA gel 24% for 2 minutes and copious rinsing with saline solution. SCTG was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material \[Vicryl suture\], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.

Modified Coronally Advanced Tunnel Technique with SCTG.; Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft; The Laterally Closed Tunnel Technique with SCTG; The Laterally Closed Tunnel Technique with collagen matrix mucograft

The Laterally Closed Tunnel Technique with collagen matrix mucograft DRUG

Local anesthesia using 4% articane with 1:100.000 epinephrine was applied.• Then specially designed tunneling instruments \[devmed\] were used through the sulcular incision to create a pouch. A microsurgical blade was used at the inner surface of the pouch till sufficient tissue release was achieved. Tissue forceps was used to approximate the mesial and distal margin of the gingiva at the pouch margin. After harvesting the graft, it was placed at the prepared pouch after root surface biomodification using EDTA gel 24% for 2 minutes and copious rinsing with saline solution. collagen matrix was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material \[Vicryl suture\], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.

Modified Coronally Advanced Tunnel Technique with SCTG.; Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft; The Laterally Closed Tunnel Technique with SCTG; The Laterally Closed Tunnel Technique with collagen matrix mucograft

Modified Coronally Advanced Tunnel Technique with SCTG. PROCEDURE

Supraperiosteal incisions was extended to the mucosal level beyond the MGJ to allow sufficient tissue mobility and release. The tunnel was extended in all directions around the recession defect to create a sufficient pouch for connective tissue graft stabilization. The interdental papilla tunneling adjacent to the defect was a critical step for technique success. Then perfect root planning was performed at the denuded root surface to remove the necrotic cementum at the accessible recession defect. Subsequently palatal anesthesia was given to harvest palatal SCTG using deepitheliailized free gingival graft (FGG) technique. SCTG was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material \[Vicryl suture\], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.

Modified Coronally Advanced Tunnel Technique with SCTG.; Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft; The Laterally Closed Tunnel Technique with SCTG; The Laterally Closed Tunnel Technique with collagen matrix mucograft

Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft DRUG

Supraperiosteal incisions was extended to the mucosal level beyond the MGJ to allow sufficient tissue mobility and release. The tunnel was extended in all directions around the recession defect to create a sufficient pouch for connective tissue graft stabilization. The interdental papilla tunneling adjacent to the defect was a critical step for technique success. Then perfect root planning was performed at the denuded root surface to remove the necrotic cementum at the accessible recession defect. Subsequently palatal anesthesia was given to harvest palatal SCTG using deepitheliailized free gingival graft (FGG) technique. collagen matrix was pulled using single or mattress sutures and the graft was fixed mesial and distal at the inner part of the pouch using resorbable suture material \[Vicryl suture\], then the graft was sutured around the neck of the CEJ by sling suture 6/0 polypropylene.

Modified Coronally Advanced Tunnel Technique with SCTG.; Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft; The Laterally Closed Tunnel Technique with SCTG; The Laterally Closed Tunnel Technique with collagen matrix mucograft

Eligibility Criteria

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

You may qualify if:

• No systemic diseases or Pregnancy.
• Smoking \< 10 cigarettes/day.
• Full mouth plaque score \<15%.
• Full mouth bleeding score \<15%.
• Presence of isolated gingival recession defect \>2 mm in depth
• No interproximal attachment loss.
• No history of previous mucogingival surgeries.

You may not qualify if:

• Sever interproximal alveolar bone loss.
• Pregnancy and lactation.
• Heavy smokers.
• Uncontrolled diabetic patients.
• Immunocompromised patients.
• Prosthetic crown at the experimental site.
• Teeth with cervical caries or abrasion.
• Presence of infection or gingival abscess related to the surgical area.
• Bad oral hygiene.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Elmansura, 35511, Egypt

Location

Related Publications (2)

• ElBana A, Saleh W, Youssef J. Comparative evaluation of the laterally closed tunnel technique with connective tissue graft and collagen matrix for treating localized type 1 gingival recession: a randomized, controlled clinical trial. BMC Oral Health. 2026 Jan 6. doi: 10.1186/s12903-025-07515-9. Online ahead of print.

  PMID: 41495722 DERIVED

• Elbana A, Saleh W, Youssef J. Comparing Connective Tissue Grafts and Collagen Matrix in Modified Coronally Advanced Tunnel Technique for RT1 Gingival Recession: A Randomized Controlled Clinical Trial. BMC Oral Health. 2025 Jun 3;25(1):893. doi: 10.1186/s12903-025-06259-w.

  PMID: 40462003 DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

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: Assistant Lecturer,Oral Medicine, Periodontology, Diagnosis and Oral Radiology Department

Model Details: The patients will be assigned into four treatment groups Group I comprises of patient undergoing The Laterally Closed Tunnel Technique with SCTG , Group II comprises of patients undergoing The Laterally Closed Tunnel Technique with collagen matrix mucograft , Group III comprises of patients undergoing Modified Coronally Advanced Tunnel Technique with SCTG and Group IV comprises of patients undergoing Modified Coronally Advanced Tunnel Technique with collagen matrix mucograft

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: October 4, 2023
• Study Start: July 17, 2022
• Primary Completion: April 2, 2024
• Study Completion: September 4, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

EG (1)