Tuberosity Versus Palatal Connective Tissue Graft on the Treatment of Single Maxillary Recession-type Defects

NCT06404762 | Completed

• 1 other identifier: E-21071282-050.99-519910
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical study is to assess the root coverage outcomes and patient morbidity following the treatment of single maxillary recession-type defects using a coronally advanced flap (CAF) combined with a subepithelial connective tissue graft (SCTG) harvested from the maxillary tuberosity (MT) versus lateral palate (LP). The secondary objective is to evaluate the histological characteristics of graft compositions harvested from the different regions (MT versus LP). Therefore, the following questions related to the study are raised:

• Do SCTGs harvested from MT (tSCTG) and LP (pSCTG) exhibit similar root coverage outcomes in the treatment of single maxillary recession-type defects using CAF?
• What are the histological characteristics of tSCTG and pSCTG? A total of 30 patients who have been referred to the Gazi University Department of Periodontology will be randomly assigned to receive tSCTG or pSCTG in combination with CAF. Clinical measurements will be recorded at baseline, 1, 3, 6, and 12 months after surgeries. Immediately after interventions; a questionnaire evaluating post-operative pain, discomfort, sensitivity, and bleeding will be given to the patients. The amount of non-steroid anti-inflammatory drugs used will be recorded at 1, 2, 3, 7, 14 and 28 days after surgery. Descriptive morphologic analysis of the grafts will be assessed in terms of the presence of inflammatory cells, connective tissue cellularity, vascularization, adipose tissue, and collagen structure.

Conditions

Gingival Recession, Localized

Keywords

Maxillary Tuberosity; Connective Tissue Graft; Coronally Advanced Flap

Outcome Measures

Primary Outcomes (1)

• The percentage of root coverage

  Mean root coverage of tSCTG versus pSCTG with CAF according to the gingival recession changes from baseline and the 1-year postoperative follow-up

  1-year postoperative follow-up

Secondary Outcomes (6)

• The percentage of complete root coverage

  1-year postoperative follow-up

• Recession depth

  1-year postoperative follow-up

• Patient morbidity - Postoperative pain

  Up to 28 days postoperatively

• Patient morbidity - Postoperative discomfort

  Up to 28 days postoperatively

• Histological features of the graft

  Through study completion, an average of 1 year

Study Arms (2)

tSCTG+ CAF

ACTIVE COMPARATOR

Single, isolated gingival recessions; excluding molars; at maxilla will be treated with subepithelial connective tissue graft harvested from the maxillary tuberosity in conjunction with a coronally advanced flap

Procedure: tSCTG+ CAF

pSCTG+ CAF

ACTIVE COMPARATOR

Single, isolated gingival recessions; excluding molars; at maxilla will be treated with subepithelial connective tissue graft harvested from the lateral palate in conjunction with a coronally advanced flap

Procedure: pSCTG+ CAF

Interventions

tSCTG+ CAF PROCEDURE

In the tSCTG group, at the distal end of a second maxillary molar, an incision will be made using a double-bladed scalpel (SKU 10-130-05D; Hu-Friedy, Chicago, IL, USA) bucco-palatally, forming a 1,5 mm thick parallel line. Secondary incisions will be made to separate the graft using a 15c blade on the buccal and palatal sides. Later, the graft will be de-epithelialized extra-orally using a blade

tSCTG+ CAF

pSCTG+ CAF PROCEDURE

In pSCTG group; the graft will be harvested through a single-incision approach at the lateral palatal mucosa

pSCTG+ CAF

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoker, systemically healthy
• No active periodontal disease
• Maxillary anterior and premolar teeth with single, isolated recessions RT 1 (Miller 1 \&2)
• Absences of non-carious cervical lesions (NCCL) and non-detectable cemento-enamel junction (CEJ)
• Buccal gingival recession defects between 2-5 mm in depth

You may not qualify if:

• Presence of caries lesions or restorations in the cervical area
• Intake of medications that impede periodontal tissue health and healing
• Medical contraindications for periodontal surgical procedures
• Pregnancy and lactation
• Bleeding and plaque scores ≥ 20%
• Probing depths \> 4 mm

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Faculty of Dentistry

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location

Related Publications (4)

• Zucchelli G, Amore C, Sforza NM, Montebugnoli L, De Sanctis M. Bilaminar techniques for the treatment of recession-type defects. A comparative clinical study. J Clin Periodontol. 2003 Oct;30(10):862-70. doi: 10.1034/j.1600-051x.2003.00397.x.

  PMID: 14710766 BACKGROUND

• Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.

  PMID: 25644302 BACKGROUND

• Jung UW, Um YJ, Choi SH. Histologic observation of soft tissue acquired from maxillary tuberosity area for root coverage. J Periodontol. 2008 May;79(5):934-40. doi: 10.1902/jop.2008.070445.

  PMID: 18454674 BACKGROUND

• Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.

  PMID: 20590963 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Model Details: Randomized controlled clinical study

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 8, 2024
• Study Start: July 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)