Clinical trial
Comparative Evaluation of Laterally Closed Tunnel (LCT) Technique and Modified Coronally Advanced Tunnel (MCAT) Technique in the Treatment of Isolated Gingival Recession: Randomized Controlled Clinical Trial
Name
A04060722
Description
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.
Trial arms
Trial start
2022-07-17
Estimated PCD
2024-04-01
Trial end
2024-09-01
Treatment
The Laterally Closed Tunnel Technique with SCTG
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.
Arms:
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
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.
Arms:
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.
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.
Arms:
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
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.
Arms:
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
Size
80
Primary endpoint
Gingival Recession Depth (RD)
6 months
Eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-10-10
1 organization
2 products
2 indications
Organization
Mansoura UniversityIndication
Gingival RecessionIndication
Localised