Root coverage outcomes of subepithelial connective tissue grafts harvesting from palate before and after recipient site preparation and viability of palatal subepithelial connective tissue graft harvests

Phase 1

Recruiting

• Conditions: Root coverage outcomes of subepithelial connective tissue grafts harvesting from palate before and after recipient site preparation.Viability of palatal subepithelial connective tissue graft harvests.; Root coverage outcomes; Graft viability; Subepithelial connective tissue grafts

• Registration Number: TCTR20230826008
• Lead Sponsor: Faculty of Dentistry, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-26
• Study Completion: 2024-03-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Part I
-Age more than 18 years old who needs a periodontal soft tissue graft treatment
-No contra-indicatory to the surgery
-Single gingival recession at buccal sites of single root teeth classified as RT1 or RT2 by Cairo, 2011
-Good inflammation control (full-mouth bleeding on probing less than 25%)
-Good plaque control (full-month plaque score less than 25%)
-Probing depth less than 4 mm at an interesting site
-No history of periodontal surgery at the recipient site
Part II
-Age more than 18 years old who needs a periodontal soft tissue graft treatment
-No contra-indicatory to the surgery.

Exclusion Criteria

Part I
- Patients who have medical contraindications to periodontal surgery
- Taking antibiotics or drugs affecting periodontal healing within 6 months.
- Excessive tooth mobility on the surgical site
- Recession defect with restoration/demineralization/caries/deep abrasion or abfraction >1mm or evidence of pulpal pathology
Part II
- Patients who have medical contraindications to periodontal surgery
- Patients who have a disease or syndrome and receive medications that affect the quantity of saliva, inflammation phase, and healing process. These include the patients who are diagnosed with xerostomia or Sjogren's syndrome; patients who take chemotherapy drugs, antiresorptive drugs, antiangiogenics drugs, steroid drugs, anti-inflammatory drugs (depending on the type of drugs, e.g., ibuprofen is eliminated in 24 hours, thus patients who take ibuprofen >24 hours before the surgery can be included), antibiotic drugs in past 6 months, immunosuppressive drugs, amphetamine/methamphetamine drugs; and patients who currently use marijuana or a current smoker.
- The biopsy site has inflamed gingival tissue (redness, swelling, or bleeding), involves an important organ at the palate, or presents any pathologic oral lesions.
- The patients undergo a soft tissue graft harvesting but the harvesting site is insufficient for another 4-mm diameter 2-mm thick biopsy sample, e.g., the area is closed to some vital structures, thin palatal tissue < 2 mm.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gingival recession reduction 3 months measurement with probe and intraoral scanner (mm)

Secondary Outcome Measures

Name	Time	Method
viability of SCTG 24 hours Prestoblue viability assay