Clinical trial NCT05270941: Platelet-Rich Fibrin Prepared With Titanium in the Treatment of Multiple Gingival Recessions
Official title: Platelet Rich Fibrin Prepared With Titanium Connective Tissue Graft in Treatment of Gingival Recessions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: recession
gingival
subepithelial connective tissue graft
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete root coverage [ Time Frame: 6 months
timeFrame: 6 MONTHS
measure: Gingival recession depth [ Time Frame: 6 months ]
timeFrame: 6 months.
Secondary outcomes:
measure: Keratinized tissue width [ Time Frame: 6 months ]
timeFrame: 6 months.
measure: Pain scores [ Time Frame: first week after operations ]
timeFrame: first week
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan Üniversitesi Diş Hekimliği Fakültesi
state: Meram
city: Konya
country: Turkey
facility: Necmettin Erbakan Üniversitesi Diş Hekimliği Fakültesi
Study officials:
References: