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

NCT ID: NCT04632693

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Gingival Thickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CAF with SCTG and vitamin C

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

Group Type EXPERIMENTAL

CAF with SCTG and Vitamin C injection

Intervention Type PROCEDURE

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

CAF with SCTG

Coronally advanced flap with subepithelial connective tissue graft.

Group Type ACTIVE_COMPARATOR

CAF with SCTG alone

Intervention Type PROCEDURE

Coronally advanced flap with subepithelial connective tissue graft.

Interventions

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CAF with SCTG and Vitamin C injection

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

Intervention Type PROCEDURE

CAF with SCTG alone

Coronally advanced flap with subepithelial connective tissue graft.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Andrew Albert Anwar Zaki

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Oral and Dental Medicine - CU

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Andrew Albert A. Zaki, MSc

Role: CONTACT

Phone: 01274805636

Email: [email protected]

Facility Contacts

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Andrew Albert A. Zaki, MSc

Role: primary

Other Identifiers

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3-6-20

Identifier Type: -

Identifier Source: org_study_id