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

Not Applicable

• Conditions: Gingival Thickness

• Registration Number: NCT04632693
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2020-09-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-16
• Last Update Submitted: 2020-11-16
• Study First Posted: 2020-11-17
• Last Update Posted: 2020-11-17
• Primary Completion: 2021-05
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ginigval thickness	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Attachment Level (CAL)	6 months	Measured from the CEJ to the bottom of the gingival sulcus.
Post-Operative Pain	2 weeks	Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively.
Root Coverage Esthetic Score	6 months	A system proposed for evaluating esthetic outcomes of root coverage procedures. The RES system evaluated five variables at 6-months after surgery: the level of the gingival margin, marginal tissue contour, soft tissue texture, MGJ alignment, and gingival color.
Early Healing Index	6 months	A system proposed for the clinical assessment of the early wound events by using a differentiated early wound healing index (EHI) (Wachtel et al., 2003).
Gingival Recession Depth (RD)	6 months	Measured from the CEJ to the most apical extension of the gingival margin.
Gingival Recession Width (RW)	6 months	Measured horizontally between the borders of the recession at the level of CEJ.
Percentage of root coverage	6 months	(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.
Post-Surgical Patient Satisfaction	6 months	A 3-item questionnaire is asked and the patients shall use a 7-point answer scale.
Probing Depth (PD)	6 months	Measured from the gingival margin to the bottom of the gingival sulcus.
Height of Keratinized Tissue (KTH)	6 months	Measured as the distance between the gingival margin and the mucogingival junction (MGJ).; All measurements will be performed by means of the UNC periodontal probe and will be rounded up to the nearest millimeter.

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine - CU; 🇪🇬 Cairo, Egypt