Titanium Prepared Platelet Rich Fibrin for Multiple Gingival Recessions

NCT03121872 | Completed

• 1 other identifier: 2014/21; date: 07.04.2014
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Titanium-prepared platelet-rich fibrin (T-PRF) is activated with titanium, which results in a more mature and aggregated form than PRF. In our previous studies, we established that the fibrin carpet formed with titanium had a firmer network structure, and longer resorption time in the tissue than the fibrin carpet formed with glass. The purpose of this randomized controlled clinical trial is to compare the effects of autogenous T-PRF and CTG. Materials and methods: A total 114 Miller Class I/II gingival recessions with abrasion defects will be treated either T-PRF (63 teeth) or CTG (51 teeth) using a modified tunnel technique. Clinical periodontal indexes, keratinized tissue (KTW), gingival thickness (GT) and recession depth (RD) will be recorded before surgery and at 6 and 12-month follow-up examinations. The Visual Analog Scale and healing index scores will be assessed.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Root Coverage Percentage at 12 months

  Preoperative recession depth - Postoperative recession depth X 100 % Preoperative recession depth

  Change from baseline Root Coverage Percentage at 12 months

Secondary Outcomes (1)

• Keratinized Tissue Width at 12 months

  Change from baseline Keratinized Tissue Width at 12 months

Study Arms (2)

Root Coverage Surgery with T-PRF

EXPERIMENTAL

Multiple gingival recessions were treated by Titanium prepared PRF (T-PRF) in 16 patients. The T-PRF membrane that was procured was placed in the defect area 1 mm beyond the enamel-cement border.. The T-PRF was fixed in the receiver area by a mattress stitch through the apical aspect using 5-0 monofilament absorbable sutures. The flap was stitched in a manner that completely covered the graft in the coronal aspect. Thereafter, the graft was fixed to the flap on the coronal aspect with horizontal mattress sutures. Compression was applied to the receiver area with serum-impregnated sterile gauze for approximately 5 minutes, and then periodontal paste was placed onto the surgery site.

Procedure: Root Coverage Surgery with T-PRF

Root Coverage Surgery with CTG

ACTIVE COMPARATOR

Multiple gingival recessions were treated by Connective Tissue Graft (CTG)in 18 patients.The CTG width was measured to include 1 mm beyond the root surface defects in the receiver area. Following anaesthesia of the palate, the borders of the start and finish incisions were marked. Subepithelial connective tissue that was 1.5-2 mm thick and excluded the periosteum was removed and maintained in physiological saline. The palate was stitched with 4-0 absorbable sutures (Pegalak, Doğsan, Turkey) and covered with a periodontal paste. Before placing the connective tissue in the receiver area, the fat and glandular tissues and the band-shaped epithelium on the connective tissue were removed using scissors.

Procedure: Root Coverage Surgery with CTG

Interventions

Root Coverage Surgery with T-PRF PROCEDURE

Root surfaces in the multiple gingival recession regions were made smooth using Gracey curettes. To remove the smear layer, 24% EDTA solution was applied to the tooth surfaces for approximately 2 minutes and then washed with physiological saline. The receiver region was prepared using the modified tunnel method. After passive stabilization of the flap in the coronal aspect, the preparation of the donor region was initiated

Root Coverage Surgery with T-PRF

Root Coverage Surgery with CTG PROCEDURE

Root surfaces in the multiple gingival recession regions were made smooth using Gracey curettes. To remove the smear layer, 24% EDTA solution was applied to the tooth surfaces for approximately 2 minutes and then washed with physiological saline. The receiver region was prepared using the modified tunnel method. After passive stabilization of the flap in the coronal aspect, the preparation of the donor region was initiated

Root Coverage Surgery with CTG

Eligibility Criteria

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

You may qualify if:

• Eligibility criteria included the following:
• Absence of systemic disease that would likely hinder periodontal surgery or unfavourably influence wound healing
• Having multiple gingival recessions including at least two adjacent Miller class I or II teeth among mandibular or maxillary incisors and premolars. Molars were excluded.
• The teeth undergoing treatment were vital with no restoration or decay in the tooth neck (collum dentis) and with a completely or partially fixable enamel-cement border
• The relevant teeth in the arch were rotation-free with no mobility
• The presence of periodontal pockets not exceeding 3 mm in the teeth undergoing treatment; the teeth had no occlusal trauma; and the patients were older than 18 years of age

You may not qualify if:

• Receiving medicines that would likely cause gingival hypertrophy
• Smokers
• Presence of blood-borne diseases
• Presence of any systemic disease likely to influence coagulation, and receiving any anticoagulant medicines

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Esra Ercan

Trabzon, Others, 61080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Esra Ercan

  Karadeniz Technical University

  STUDY DIRECTOR

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 Proffesor Doctor

Model Details: In this randomized controlled clinical trial, multiple gingival recessions were treated by T-PRF in 16 patients and by CTG in 18 patients selected by the coin-toss method. All surgical procedures, measurements and follow-up were performed by the same clinician

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 20, 2017
• Study Start: May 21, 2014
• Primary Completion: May 20, 2016
• Study Completion: August 5, 2016
• Last Updated: April 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)