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Completed

NCT Number: NCT06404762

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Faculty of Dentistry

Ankara, Çankaya, 06490, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

pSCTG+ CAF

Procedure

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

Primary outcomes

  1. The percentage of root coverage

    Time frame: 1-year postoperative follow-up

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

Secondary outcomes

  1. The percentage of complete root coverage

    Time frame: 1-year postoperative follow-up

    After the 1-year postoperatively, absence of gingival recession

  2. Recession depth

    Time frame: 1-year postoperative follow-up

    The distance between cemento-enamel junction and gingival margin

  3. Patient morbidity - Postoperative pain

    Time frame: Up to 28 days postoperatively

    Postoperative pain will be assessed using a visual analogue score

  4. Patient morbidity - Postoperative discomfort

    Time frame: Up to 28 days postoperatively

    Postoperative discomfort will be assessed using a visual analogue score

  5. Histological features of the graft

    Time frame: Through study completion, an average of 1 year

    Graft cellularity

  6. Histomorphometrical features of the graft

    Time frame: Through study completion, an average of 1 year

    The amount of lamina propria

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 8, 2024
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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