Connective Tissue Graft Wall Technique in Management of Cairo's RT2 and RT3 With Intra-bony Defects

NCT04514055 | Completed

• 1 other identifier: 14422019493595
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Recession presents a day to day challenge due to the high esthetic demand of the patients. The prevalence, extent, and severity of recession associated with intra-bony defects due to periodontitis increases with age rendering the success of the root coverage procedures questionable due to loss of interdental papillary support. . Therefore, connective tissue graft wall technique in cases of Cairo's RT2 and RT3 gingival recession associated with intra bony defects seems promising with regard to recession depth reduction and radiographic bone fill.

Conditions

Recession, Gingival

Outcome Measures

Primary Outcomes (1)

• Gingival recession depth

  Measured from the cementoenamel junction to the gingival margin using a William's graduated periodontal probe. The probe will be inserted into the sulcus gently parallel to the long axis of the tooth.

  Changes at 3 and 6 months post-operative

Secondary Outcomes (11)

• Radiographic bone fill

  At 6 months post-operative

• Gingival Recession Width

  Changes at 3 and 6 months post-operative

• Percentage of Root Coverage

  Changes at 3 and 6 months post-operative

• Gingival Thickness

  Changes at 3 and 6 months post-operative

• Probing Depth

  Changes at 3 and 6 months post-operative

Study Arms (1)

De-epithelialized connective tissue graft wall

EXPERIMENTAL

Simplified papilla preservation flap will be applied in the narrow interproximal spaces (≤2 mm), where an oblique incision starting from the gingival margin at the buccal-line angle of the involved tooth reaching the mid-interproximal portion of the papilla under the contact point of the adjacent tooth will be performed using a 15c blade. A free gingival graft will be obtained from the hard palate and de-epithelized extra-orally. A Coronally advanced flap will be performed. The de-epithelialized FGG will be sutured coronally using a 6-0 vicryl suture to the anatomical papillae of the two teeth adjacent to the defect and apically to the periosteum left in place apical to the exposed bone. The flap will be sutured using internal Horizontal mattress suture at the base of the simplified papilla and a vertical mattress suture will be placed in a more coronal position so complete soft tissue closure can be obtained.

Procedure: De-epithelialized connective tissue graft wall

Interventions

De-epithelialized connective tissue graft wall PROCEDURE

A de-epithelialized free gingival connective tissue graft will be used to treat Cairo's recession type 2 and type 3 associated with inta-bony defects

De-epithelialized connective tissue graft wall

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Teeth with buccal RT2 and RT3 recession associated with an intra-bony defect on single rooted teeth.
• Single and multiple recessions.
• Full mouth plaque score (FMPS )\<20% at baseline.
• Full mouth bleeding score (FMBS )\<10% at baseline.
• Systemically healthy.
• Cooperative patients.

You may not qualify if:

• Smokers.
• Pregnancy and lactation.
• Stage 4 Grade C periodontitis.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry Cairo University

Cairo, 11552, Egypt

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Mariam Bendary

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: October 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After completion of the study
• Access Criteria: ClinicalTrials.gov

Locations

EG (1)