Clinical trial NCT04632693: Soft Tissue Augmentation Using CAF With Either SCTG and Vitamin C Versus SCTG Alone in Management of RT1 Gingival Recession
Official title: Soft Tissue Augmentation Using Coronally Advanced Flap With Either Subepithelial Connective Tissue and Vitamin C Versus Subepithelial Connective Tissue Graft Alone in Management of RT1 Gingival Recession
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Thickness
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Control group (coronally advanced flap and subepithelial connective tissue graft alone) Test group (coronally advanced flap and subepithelial connective tissue graft using microsurgical approach) Same procedure will be executed but with the addition of vitamin C injection. Intraepidermal injection (oral mesotherapy technique) of 1-1.5 ml (200-300 mg concentration) of L-ascorbic acid will be done. It will be locally introduced in relation to the keratinized gingival tissues with extension to the whole target region successively using special syringes (30 gauge). The needle will be introduced parallel to the gingival tissues with the bevel facing upwards. Vitamin C will then be delivered through the attached gingival tissues at the epithelium-connective tissue junction (equivalent to epidermal- dermal junction) till the tissues blanch. Vitamin C will be injected first time immediately postsurgical and then repeated once per week for 3 consecutive weeks for a total of 4 injections.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Ginigval thickness
timeFrame: 6 months
Secondary outcomes:
measure: Root Coverage Esthetic Score
timeFrame: 6 months
measure: Early Healing Index
timeFrame: 6 months
measure: Gingival Recession Depth (RD)
timeFrame: 6 months
measure: Gingival Recession Width (RW)
timeFrame: 6 months
measure: Percentage of root coverage
timeFrame: 6 months
measure: Probing Depth (PD)
timeFrame: 6 months
measure: Clinical Attachment Level (CAL)
timeFrame: 6 months
measure: Height of Keratinized Tissue (KTH)
timeFrame: 6 months
measure: Post-Operative Pain
timeFrame: 2 weeks
measure: Post-Surgical Patient Satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine - CU
Study officials:
References: