Ultrasonographic Evaluation of the Connective Tissue Grafts Obtained With Two Different Methods in Root Coverage

NCT06373783 | Completed

• 1 other identifier: 2023/05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Gingival recession is a clinical problem that increases with age and affects patient comfort. It is defined as the displacement of the gingival margin to a more apical position of the cementum-enamel border of the tooth. Coronally advanced flap (CAF) or tunnel technique (TUN) with subepithelial connective tissue procedures have been reported to be the most predictable methods of single gingival recession treatments. The ultimate goal of these plastic periodontal surgical procedures is to close the exposed root surface and achieve optimum aesthetic results. The main indications for root coverage (RC) procedures are aesthetic concern, root hypersensitivity, prevention of cervical abrasion and root caries, improvement of restorative results, and facilitation of plaque control. The use of a subepithelial connective tissue graft (SCGT) combined with a coronally positioned flap is considered the gold standard by many authors for single gingival recession treatments. De-epithelialization of free gingival grafts (DGG) has been proposed, especially when palatal tissue thickness is insufficient (≤2.5 mm) and larger graft size in the apico-coronal or mesio-distal directions is required. In this technique, the graft of the required width and length is separated from the lateral side of the palate, and then the 0.3-0.5 mm thick epithelial layer of the resulting graft is cut from the connective tissue layer. Ultrasonography (USG) is based on the principle of recording data obtained as a result of ultrasound waves sent with the help of a probe hitting and reflecting on substances of different densities. This technique is widely used in medical practice. In dentistry, the USG method is used to measure the alveolar bone level and the dimensions of the periodontium to evaluate the gingival thickness. It also has functions to evaluate color power and color speed, as well as blood flow. The study hypothesizes that combining SCGT and DGG with a coronally positioned flap could yield different clinical outcomes in patients with a single buccal gingival recession. This study aims to compare the clinical success of connective tissue grafts obtained by two different surgical methods in covering the root surface with ultrasonography (USG).

Conditions

Gingival Recession, Localized

Keywords

Connective tissue graft; gingival recession; ultrasonography; de-epithelized gingival graft; tissue thickness; blood-flow velocity

Outcome Measures

Primary Outcomes (1)

• tissue thickness

  tissue thickness was measured with B-Mod mod of ultrasonography device

  at baseline before operation, on days 3,14, 30, 90,180

Secondary Outcomes (1)

• pulsatility index

  at baseline before operation, on days 3,14,30,90,180

Study Arms (2)

de-epithelise

ACTIVE COMPARATOR

In combination with Zuchelli's coronally positioned flap technique, gingival recession in the upper jaw premolar region was treated using a de-epithelialized gingival graft. The gingival graft was taken in a rectangular shape from the area located on the palatal side of the maxillary canine and the first molar tooth, and then it was de-epithelised with the help of a scalpel.

Procedure: de- epithelize gingival graft; Diagnostic Test: ultrasonography

subepithelial

ACTIVE COMPARATOR

In combination with Zuchelli's coronally positioned flap technique, gingival recession in the upper jaw premolar region was treated using a subepithelial gingival graft. Connective tissue taken from the upper jaw-palate region with a single incision technique was used.

Procedure: subepithelial connective tissue graft; Diagnostic Test: ultrasonography

Interventions

subepithelial connective tissue graft PROCEDURE

The area where the gingival recession occurred was prepared with the modified coronally positioned flap technique developed by Zuchelli. The subepithelial connective tissue graft was obtained in each patient using the single incision technique from the region between the mesial of the canine and the mesial of the first molar in the palate. Connective tissue dimensions were approximately 10x5x2 mm. The graft thickness was measured with an endodontic spreader from 3 points (mesial, buccal, and distal) and an electronic caliper during surgery.

subepithelial

de- epithelize gingival graft PROCEDURE

The area where the gingival recession occurred was prepared with the modified coronally positioned flap technique developed by Zuchelli. A shallow horizontal incision was made at ≈3 mm apical from the gingival margin of the maxillary molar teeth using a number 15 scalpel blade. Subsequently, a parallel horizontal incision, at ≈ 4 mm apical from the first horizontal incision, was traced in conjunction with two vertical releasing incisions to delineate a rectangular area. Then, the uppermost epithelial layer was scraped off using a size 11 scalpel tip. The connective tissue graft to be taken from the palate area was 10x5x2 mm in size, and the graft thickness was measured with an endodontic spreader from 3 points (mesial, buccal, and distal) and electronic caliper during surgery.

de-epithelise

ultrasonography DIAGNOSTIC_TEST

Clinical parameter measurements (probing depth (PD), clinical attachment level (CAL), gingival recession depth and width, keratinized tissue width and height) were taken on the day of surgery, the 3rd days, the 14th days, the 1st month, the 3rd months and the 6th months. Ultrasonography measurements A 6-18 MHz intraoral probe was used in intraoral USG examinations. Sterile gel was applied to the intraoral probe and covered with a stretch film. Then, it was placed directly on the mucosal surface of the receiver site in the buccal area. Mucosal thickness was evaluated using the B-mode of the device, and vascularization was evaluated using the color doppler and pulsed wave doppler modes of the device. The following equation is used and calculated by US unit pulsatility index (PI) = (Vmax-Vmin) (Vmean) (Vmax is peak systolic flow velocity. Vmin is diastolic flow velocity and Vmean is mean flow velocity.) The mean PI values of each patient were measured.

de-epithelise; subepithelial

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with single Miller class 1 or 2 gingival recession who have undergone root coverage surgery.
• to 65 years old
• non-smoker and non-alcoholic.
• Patients who have good oral hygiene and whose inflammation can be controlled (FMPS \<25%, FMBS \<25%, probing depth ≤ 3mm, and bleeding on probing \<10%)
• Those who have no previous history of periodontal surgery in the operation area

You may not qualify if:

• Active smokers
• pregnancy and lactation
• Continuation of gingival trauma due to false tooth brushing
• Presence of severe tooth malposition
• Those with systemic diseases that may affect wound healing after periodontal surgery
• Individuals who cannot maintain oral hygiene

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University of the Dentistry

Denizli, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• GİZEM TORUMTAY CİN, assist prof.

  PAMUKKALE UNIVERSITY FACULTY of DENTISTIRY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asistant prof.

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 18, 2024
• Study Start: June 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: March 16, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

TU (1)