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Gingival RecessionNCT05270941

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

A study testing COMPARISON OF PLATELET-RICH FIBRIN PREPARED WITH TITANIUM AND SUBEPITHELIAL CONNECTIVE TISSUE GRAFT in people with Gingival Recession, run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
COMPARISON OF PLATELET-RICH FIBRIN PREPARED WITH TITANIUM AND SUBEPITHELIAL CONNECTIVE TISSUE GRAFT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesTurkey (Türkiye)
Study dates
12 Jan 2019to 30 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Necmettin Erbakan Üniversitesi Diş Hekimliği Fakültesi

    Konya, Meram, 42050

  • Necmettin Erbakan Üniversitesi Diş Hekimliği Fakültesi

    Konya, 42050

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
COMPARISON OF PLATELET-RICH FIBRIN PREPARED WITH TITANIUM AND SUBEPITHELIAL CONNECTIVE TISSUE GRAFT
Keywords
recession, gingival, subepithelial connective tissue graft
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COMPARISON OF PLATELET-RICH FIBRIN PREPARED WITH TITANIUM AND SUBEPITHELIAL CONNECTIVE TISSUE GRAFTProcedure or surgery

    Also called MODİFİYE CORONALLY ADVANCED FLAP

    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.

Study groups in NCT05270941
Study groupRoleWhat they receive
Control GroupsActive comparatorControl 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
Receives: Procedure: COMPARISON OF PLATELET-RICH FIBRIN PREPARED WITH TITANIUM AND SUBEPITHELIAL CONNECTIVE TISSUE GRAFT
Test GroupExperimentalTest 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
Receives: Procedure: COMPARISON OF PLATELET-RICH FIBRIN PREPARED WITH TITANIUM AND SUBEPITHELIAL CONNECTIVE TISSUE GRAFT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete root coverage [ Time Frame: 6 months

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

    Measured: 6 MONTHS

  2. Gingival recession depth [ Time Frame: 6 months ]

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

    Measured: 6 months.

Secondary outcomes (2)
  1. Keratinized tissue width [ Time Frame: 6 months ]

    Change from baseline in keratinized tissue at 6 months.

    Measured: 6 months.

  2. Pain scores [ Time Frame: first week after operations ]

    Pain level evaluated on visual analog scale

    Measured: first week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2022
  2. Study start12 Jan 2019
  3. Primary completion29 Nov 2020
  4. Study completion30 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05270941
Sponsor's protocol ID
dilek özkan şen
Status last verified
Feb 2022
First submitted
12 Feb 2022
Last updated
8 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing COMPARISON OF PLATELET-RICH FIBRIN PREPARED WITH TITANIUM AND SUBEPITHELIAL CONNECTIVE TISSUE GRAFT in people with Gingival Recession, run by Necmettin Erbakan University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete root coverage [ Time Frame: 6 months (time frame: 6 MONTHS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.

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