Platelet-Rich Fibrin Prepared With Titanium in the Treatment of Multiple Gingival Recessions

Gingival Recession Clinical Trial

Official title:

Platelet Rich Fibrin Prepared With Titanium Connective Tissue Graft in Treatment of Gingival Recessions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05270941
• Other study ID #: dilek özkan sen
• Status: Completed
• Phase: N/A
• Start date: January 12, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2022
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to treat the areas with Miller Class I bilateral multiple gingival recession in the maxillary teeth using the Titanium Platelet-Rich Fibrin (T-PRF), an autogenous biomaterial applied in combination with a Modified Coronally Positioned Flap (MCPF) prepared using microsurgical techniques, and the gold standard Subepithelial Connective Tissue Graft (SCTG), to evaluate the efficacy of the treatments and to compare the clinical results 6 months after the treatment.

Description:

AİM:

The aim of this study was to treat the areas with Miller Class I bilateral multiple gingival recession in the maxillary teeth using the Titanium Platelet-Rich Fibrin (T-PRF), an autogenous biomaterial applied in combination with a Modified Coronally Positioned Flap (MCPF) prepared using microsurgical techniques, and the gold standard Subepithelial Connective Tissue Graft (SCTG), to evaluate the efficacy of the treatments and to compare the clinical results 6 months after the treatment.

MATERIALS AND METHODS A total of 20 patients (118 defects), consisting of 13 females and 7 males, with maxillary bilateral Miller Class I gingival recession who were aged between 18 and 65, applied to Necmettin Erbakan University, Faculty of Dentistry, Department of Periodontology and had aesthetic anxiety and sensitivity problems due to multiple gingival recessions were included in our study. As a randomized controlled clinical trial, in the patients' bilateral recession sites, while gingival recessions of one group were treated with T-PRF, the gingival recessions of the other group were treated with SCTG using a simple randomization method. The study protocol was in accordance with the Declaration of Helsinki of 1975, as revised in 2002 and was submitted to and approved by the ethical committee of Necmettin Erbakan University and the Ministry of Health General Directorate of Health Services (protocol number:2019/238). All patients included in the study were given detailed information about the clinical trial, and their written informed consent was obtained. The study was performed between January 2019 and November 2020 in Necmettin Erbakan University Department of Periodontology.

The individuals were divided into 2 groups in accordance with the study protocol:

Group1: SCTG group (n=60) Group2: T-PRF group (n=58) The criteria for inclusion in the study were determined as systemically and periodontally healthy volunteers between the ages of 18-65, the absence of parafunctional habits, non-smoking, the presence of Miller Class I gingival recession defect in teeth located in the bilateral maxillary region, the absence of any hard tissue defects in the relevant region and the absence of a restorative, endodontic procedure or periodontal surgical intervention, a full-mouth plaque score (FMPS) of ≤ 25%, having a marginal gingival thickness of at least 1 mm in the area with gingival recession, the absence of a shallow hard palate dome, having a soft tissue thickness of at least 3 mm, the absence of torus in the area where the graft was taken, the absence of any systemic disease, not using antibiotics for any reason in the last 6 months, the presence of at least 20 teeth in the mouth, not being pregnant and breastfeeding, and patients who applied to the periodontology clinic with various periodontal problems and were indicated for connective tissue graft operation due to gingival recession. The individuals who were outside the exclusion criteria and did not agree to participate in the study were excluded from the study.

In the study with a sample size of 118, the effect size value (G * Power 3.1 for Windows) calculated based on the power (1-β err probe) = 95% and α = 5% t-test was determined as 0.334 for the analysis of repeated measurements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2020
• Est. primary completion date: November 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• The criteria for inclusion in the study were determined as systemically and periodontally healthy volunteers between the ages of 18-65,

• the absence of parafunctional habits, non-smoking

• the presence of Miller Class I gingival recession defect in teeth located in the bilateral maxillary region

• the absence of any hard tissue defects in the relevant region and the absence of a restorative, endodontic procedure or periodontal surgical intervention

• a full-mouth plaque score (FMPS) of = 25%

• having a marginal gingival thickness of at least 1 mm in the area with gingival recession

• the absence of a shallow hard palate dome

• having a soft tissue thickness of at least 3 mm

• the absence of torus in the area where the graft was taken

• the absence of any systemic disease

• not using antibiotics for any reason in the last 6 months

• the presence of at least 20 teeth in the mouth

• not being pregnant and breastfeeding, and patients who applied to the periodontology clinic with various periodontal problems and were indicated for connective tissue graft operation due to gingival recession

Exclusion Criteria:

• The individuals who were outside the exclusion criteria and did not agree to participate in the study were excluded from the study.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• COMPARISON OF PLATELET-RICH FIBRIN PREPARED WITH TITANIUM AND SUBEPITHELIAL CONNECTIVE TISSUE GRAFT
In the study, 118 maxillary bilateral multiple Miller Class I gingival recessions in 20 patients were treated. The gingival recessions were randomly treated with either T-PRF (58 teeth) or SCTG (60 teeth) using the modified coronally positioned flap technique. Gingival index, plaque index, probing pocket depth, gingival thickness, recession height, recession width, keratinized gingival width, and open root surface area were measured and recorded at baseline and at the 6th month. Postoperative pain levels were evaluated using the VAS (Visual Analogue Scale), and healing status was evaluated using the wound healing index. The pre- and post-treatment results of both treatment groups and the differences between the groups were evaluated and compared.

Locations

Country	Name	City	State
Turkey	Necmettin Erbakan Üniversitesi Dis Hekimligi Fakültesi	Konya	Meram
Turkey	Necmettin Erbakan Üniversitesi Dis Hekimligi Fakültesi	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete root coverage [ Time Frame: 6 months	Change from baseline in gingival recession was be assessed at 1, and 6 months.	6 MONTHS
Primary	Gingival recession depth [ Time Frame: 6 months ]	Change from baseline in gingival recession was be assessed at 6 months	6 months.
Secondary	Keratinized tissue width [ Time Frame: 6 months ]	Change from baseline in keratinized tissue at 6 months.	6 months.
Secondary	Pain scores [ Time Frame: first week after operations ]	Pain level evaluated on visual analog scale	first week