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

Gingival Recession, Localized Clinical Trial

Official title:

Comparison of Subepithelial Connective Tissue Grafts Harvested From the Maxillary Tuberosity or Lateral Palate in the Treatment of Single Maxillary Recession-type Defects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06404762
• Other study ID #: E-21071282-050.99-519910
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: May 2024
• Source: Gazi University
• Contact: Assoc Prof Dr, PhD
• Phone: +905069966074
• Email: silaisler[@]gazi.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The treatment of gingival recessions using the coronally advanced flap (CAF) in combination with palatal subepithelial connective tissue graft (pSCTG) is highly predictable and frequently accepted in periodontal plastic-aesthetic surgeries. However, due to its limitations and disadvantages, clinicians often use grafts harvested from different autogenous areas or multiple non-autogenous materials as an alternative.

CAF combined with pSCTG is considered the gold standard for root coverage procedures. However, factors such as the density of vascular structures, a close approximation to nerves, and postoperative morbidity remain concerning for clinicians using palatal connective tissue grafts. Because of this, researchers have sought different techniques for palatal connective tissue harvesting and/or different autogenous donor areas. The maxillary tuberosity region has been found to have a denser lamina propria and is farther from nerve/vascular bundles.

Despite differences in harvesting techniques, literature has presented similar root coverage outcomes, lesser post-operative bleeding, and pain for SCTGs harvested from the maxillary tuberosity (tSCTG) compared to pSCTG groups. Decreased post-operative pain after tSCTG harvesting could be explained by higher amounts of connective tissue present in the donor area after harvesting and avoiding trauma created by food consumption and tongue movements in the region. Clinical data also showed an increased amount of keratinized tissue and its stability after augmentation, favoring tSCTG. Considering structural differences, literature has shown that tSCTG provides more thickness, a more abundant lamina propria, and denser collagen compared to pSCTG. However, due to the size of the harvested tSCTG not being as abundant as pSCTG, it can be assumed that the augmented areas were limited to multiple recessions or defects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recession, Localized

Intervention

Procedure:
• tSCTG+ CAF
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
• pSCTG+ CAF
In pSCTG group; the graft will be harvested through a single-incision approach at the lateral palatal mucosa

Locations

Country	Name	City	State
Turkey	Gazi University Faculty of Dentistry	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

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. — View Citation

Rojo E, Stroppa G, Sanz-Martin I, Gonzalez-Martin O, Alemany AS, Nart J. Soft tissue volume gain around dental implants using autogenous subepithelial connective tissue grafts harvested from the lateral palate or tuberosity area. A randomized controlled clinical study. J Clin Periodontol. 2018 Apr;45(4):495-503. doi: 10.1111/jcpe.12869. Epub 2018 Feb 23. — View Citation

Sanz-Martin I, Rojo E, Maldonado E, Stroppa G, Nart J, Sanz M. Structural and histological differences between connective tissue grafts harvested from the lateral palatal mucosa or from the tuberosity area. Clin Oral Investig. 2019 Feb;23(2):957-964. doi: 10.1007/s00784-018-2516-9. Epub 2018 Jun 18. — View Citation

Studer SP, Allen EP, Rees TC, Kouba A. The thickness of masticatory mucosa in the human hard palate and tuberosity as potential donor sites for ridge augmentation procedures. J Periodontol. 1997 Feb;68(2):145-51. doi: 10.1902/jop.1997.68.2.145. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The percentage of complete root coverage	After the 1-year postoperatively, absence of gingival recession	1-year postoperative follow-up
Secondary	Recession depth	The distance between cemento-enamel junction and gingival margin	1-year postoperative follow-up
Secondary	Patient morbidity - Postoperative pain	Postoperative pain will be assessed using a visual analogue score	Up to 28 days postoperatively
Secondary	Patient morbidity - Postoperative discomfort	Postoperative discomfort will be assessed using a visual analogue score	Up to 28 days postoperatively
Secondary	Histological features of the graft	Graft cellularity	Through study completion, an average of 1 year
Secondary	Histomorphometrical features of the graft	The amount of lamina propria	Through study completion, an average of 1 year