Soft Tissue Augmentation Using CAF With Either SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession

NCT04632693 | Unknown DMC

• 1 other identifier: 3-6-20
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Compare gingival thickness following CAF With SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession.

Conditions

Gingival Thickness

Outcome Measures

Primary Outcomes (1)

• Ginigval thickness

  Determined 2 mm apical to the gingival margin with a short needle for anesthesia and a 3 mm diameter silicon disk stop. The needle is inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface is felt. The silicon disk stop is then placed in tight contact with the soft tissue surface with the coronal border overlapping the soft tissue margin. As the needle is located in the center of the silicon disk, measurement of GT is performed 2 mm apical from the gingival margin. Once in the correct position, the disk is fixed with a drop of cyanocrylic adhesive; after careful removal of the needle, the penetration depth is measured with a caliper accurate to the nearest 0.1 mm.

  6 months

Secondary Outcomes (10)

• Root Coverage Esthetic Score

  6 months

• Early Healing Index

  6 months

• Gingival Recession Depth (RD)

  6 months

• Gingival Recession Width (RW)

  6 months

• Percentage of root coverage

  6 months

Study Arms (2)

CAF with SCTG and vitamin C

EXPERIMENTAL

Coronally advanced flap with subepithelial connective tissue graft and vitamin C.

Procedure: CAF with SCTG and Vitamin C injection

CAF with SCTG

ACTIVE COMPARATOR

Coronally advanced flap with subepithelial connective tissue graft.

Procedure: CAF with SCTG alone

Interventions

CAF with SCTG and Vitamin C injection PROCEDURE

Injection of vitamin C after CAF with SCTG aiming to increase gingival thickness in patients with RT1 gingival recession.

CAF with SCTG and vitamin C

CAF with SCTG alone PROCEDURE

Coronally advanced flap with subepithelial connective tissue graft.

CAF with SCTG

Eligibility Criteria

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

You may qualify if:

• Patients 18 years or older.
• Periodontally and systemically healthy.
• Buccal recession defects classified as Cairo RT1.
• Presence of identifiable CEJ (Zucchelli et al., 2010).
• Clinical indication and/or patient request for recession coverage.
• O'Leary index less than 20% (O'Leary, Drake and Naylor, 1972).

You may not qualify if:

• Cairo RT2 or RT3 recession defects.
• Pregnant females.
• Smokers as smoking is a contraindication for any periodontal plastic surgery (Khuller, 2009).
• Handicapped and mentally retarded patients.
• Patients undergoing radiotherapy.
• Teeth with cervical restorations, abrasion and malalignment.
• Presence of systemic disease that would affect wound healing.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Oral and Dental Medicine - CU

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Andrew Albert A. Zaki, MSc

CONTACT

01274805636; andrew.anwar@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 17, 2020
• Study Start: September 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

EG (1)