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

NCT05270941 | Completed

• 1 other identifier: dilek özkan şen
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Gingival Recession

Keywords

recession; gingival; subepithelial connective tissue graft

Outcome Measures

Primary Outcomes (2)

• Complete root coverage [ Time Frame: 6 months

  Change from baseline in gingival recession was be assessed at 1, and 6 months.

  6 MONTHS

• Gingival recession depth [ Time Frame: 6 months ]

  Change from baseline in gingival recession was be assessed at 6 months

  6 months.

Secondary Outcomes (2)

• Keratinized tissue width [ Time Frame: 6 months ]

  6 months.

• Pain scores [ Time Frame: first week after operations ]

  first week

Study Arms (2)

Control Groups

ACTIVE COMPARATOR

Control groups. This clinical trial was designed as a split-mouth, randomized, controlled clinical trial. Bilateral gingival recession defects were randomly assigned to the test (CAF+T-PRF) or control (CAF+SCTG) groups after initially evaluating the clinical parameters and randomized by coin flip method. Intervention: Procedure: Control groups

Procedure: COMPARISON OF PLATELET-RICH FIBRIN PREPARED WITH TITANIUM AND SUBEPITHELIAL CONNECTIVE TISSUE GRAFT

Test Group

EXPERIMENTAL

Test groups. This clinical trial was designed as a split-mouth, randomized, controlled clinical trial. Bilateral gingival recession defects were randomly assigned to the test (CAF+T-PRF) or control (CAF+SCTG) groups after initially evaluating the clinical parameters and randomized by coin flip method. Intervention: Procedure: Control groups Intervention: Procedure: test groups

Procedure: COMPARISON OF PLATELET-RICH FIBRIN PREPARED WITH TITANIUM AND SUBEPITHELIAL CONNECTIVE TISSUE GRAFT

Interventions

COMPARISON OF PLATELET-RICH FIBRIN PREPARED WITH TITANIUM AND SUBEPITHELIAL CONNECTIVE TISSUE GRAFT PROCEDURE

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.

Also known as: MODİFİYE CORONALLY ADVANCED FLAP

Control Groups; Test Group

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (2)

Necmettin Erbakan Üniversitesi Diş Hekimliği Fakültesi

Konya, Meram, 42050, Turkey (Türkiye)

Location

Necmettin Erbakan Üniversitesi Diş Hekimliği Fakültesi

Konya, 42050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Titanium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Metals, Light; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. öğr. üyesi

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2022
• First Posted: March 8, 2022
• Study Start: January 12, 2019
• Primary Completion: November 29, 2020
• Study Completion: November 30, 2020
• Last Updated: March 8, 2022

Record last verified: 2022-02

Locations

TU (2)