Ultrasonographic Assessment of Palatal Wound Healing

NCT06118177 | Completed

• 1 other identifier: 16.08.2022/12
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Palatal-tissue harvesting is a routinely performed procedure in periodontal plastic surgery. Subepithelial connective tissue graft (sCTG) is considered the gold standard in root coverage. However, over the years, several materials have been attempted to accelerate wound healing and to decrease the post-operative patient discomfort and pain, which are considered the most common disadvantages of tissue harvesting from the palate. Reharvesting from the same region could be necessary in some complicated gingical recessions. For this reason, patients may face long treatment times due to recovery periods of the palate between surgeries. Platelet-rich fibrin (PRF) which has 3-dimensional fibrin matrix structure contributes to regeneration of surgical wounds by releasing growth factors for 10-14 days and showing angiogenic properties. In medicine and dentistry, ultrasonography (USG) method can be used to measure tissue thickness, vascularization, elasticity and blood flow. USG, as a non-invasive method, can provide objective data in evaluating the effects of surgical techniques and biomaterials used on soft tissue healing dynamics and tissue perfusion. The investigators hypothesised that leukocyte rich PRF (L-PRF) application to the palatal area after sCTG harvesting could increase palatal tissue thickness and vascularity throughout 3-month follow-up period compared to the controls. Therefore, in this study, the investigators aimed to evaluate the effects of the L-PRF membrane on soft tissue donor site healing after harvesting sCTG in terms of wound healing dynamics using USG method.

Conditions

Gingival Recession; Palate; Wound

Keywords

platelet-rich fibrin; wound healing; ultrasonography; 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, 7, 14, 21, 30, 90

Secondary Outcomes (1)

• pulsatility index

  at baseline immediately after the operation, on days 3, 7, 14, 30, 90

Study Arms (2)

Test group

20-ml blood samples were taken from the antecubital vein of the patient's right or left arm in one attempt. The blood was gently transferred to glass-coated plastic tubes free from anticoagulant agents without wasting time. The tubes were immediately centrifuged at 2800 rpm for 12 min with a centrifuge device. After the subepithelial connective tissue graft harvesting from in the palate, obtained L-PRF was placed into donor site at the palate then incision line was suturedwith 5/0 synthetic, non-absorbable, sterile monofilament suture.

Procedure: connective tissue harvesting; Diagnostic Test: ultrasonography; Other: autolog platelet rich fibrin application

Control group

After the subepithelial connective tissue graft harvesting from in the palate, the incision line was sutured with 5/0 synthetic, nonabsorbable, sterile monofilament suture. No additional material was performed into the donör area.

Procedure: connective tissue harvesting; Diagnostic Test: ultrasonography

Interventions

connective tissue harvesting PROCEDURE

The subepithelial connective tissue graft was obtained in each patient using the single incision technique from the region between the mesial of canine and the mesial of first molar in the palate. Connective tissue dimensions were approximately 10 × 5 × 2 mm. Finally, the incision line was sutured with 5/0 synthetic, nonabsorbable, sterile monofilament suture

Control group; Test group

ultrasonography DIAGNOSTIC_TEST

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 donor site in the palatal 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: Pulsality 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.

Control group; Test group

autolog platelet rich fibrin application OTHER

Leukocyte rich PRF (L-PRF) was obtained with the centrifugation of the two tubes at 2800 rpm for 12 minutes. After centrifugation, L-PRF clots were taken from the tubes using sterile tweezers, separated from the red blood cell base using scissors. Then L-PRF membrane was placed into the donor site.

Test group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Miller 1 and 2 gingival recession who need root coverage treatment

You may qualify if:

• Need connective tissue for tunnel operation or coronally flap operation for the treatment of gingival recession
• Non-smoking
• Good oral hygiene
• No gag reflex
• No periodontal surgery before at operation site

You may not qualify if:

• Systemic disorders (immunologic diseases, uncontrolled diabetes mellitus, ongoing chemotherapy or radiotherapy)
• Pregnancy/lactation/menstruation
• Inability or unwillingness to provide informed consent

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Faculty of Dentistry

Denizli, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession; Wounds and Injuries

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

• Gizem Torumtay Cin, asist.prof.

  Pamukkale University Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: September 5, 2022
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

TU (1)