Clinical trial NCT06404762: Tuberosity Versus Palatal Connective Tissue Graft on the Treatment of Single Maxillary Recession-type Defects
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession, Localized
Keywords: Maxillary Tuberosity
Connective Tissue Graft
Coronally Advanced Flap
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical study
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The percentage of root coverage
timeFrame: 1-year postoperative follow-up
Secondary outcomes:
measure: The percentage of complete root coverage
timeFrame: 1-year postoperative follow-up
measure: Recession depth
timeFrame: 1-year postoperative follow-up
measure: Patient morbidity - Postoperative pain
timeFrame: Up to 28 days postoperatively
measure: Patient morbidity - Postoperative discomfort
timeFrame: Up to 28 days postoperatively
measure: Histological features of the graft
timeFrame: Through study completion, an average of 1 year
measure: Histomorphometrical features of the graft
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Dentistry
state: Çankaya
Study officials:
References:
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.
citation: 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.
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.
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.