NCT02335866

Brief Summary

The main objective of this study was to evaluate the clinical effectiveness of platelet-rich fibrin membrane used in combination with a coronally advanced flap and to compare it with the use of a subepitelial connective tissue graft in combination with a coronally advanced flap in Miller class I-II bilateral gingival recession treatment

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2014

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2015

Completed
Last Updated

January 12, 2015

Status Verified

January 1, 2015

Enrollment Period

Same day

First QC Date

December 13, 2014

Last Update Submit

January 7, 2015

Conditions

Gingival Recessions

Keywords

Platelet rich fibrinGingival Recession

Outcome Measures

Primary Outcomes (2)

  • Complete root coverage

    Change from baseline in gingival recession will be assessed at 1, 3 and 6 months.

    6 months

  • Gingival recession depth

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

    6 months

Secondary Outcomes (2)

  • Keratinized tissue width

    6 months

  • Pain scores

    first week after operations

Study Arms (2)

Test groups.

EXPERIMENTAL

This clinical study was designed as a split-mouth, randomized, controlled clinical trial. Bilateral gingival recession defects were randomly assigned to the test (CAF+PRF) or the control (CAF+SCTG) groups with the use of computer-generated randomization table after assessment of clinical parameters at baseline.

Procedure: test groups

Control groups.

ACTIVE COMPARATOR

This clinical study was designed as a split-mouth, randomized, controlled clinical trial. Bilateral gingival recession defects were randomly assigned to the test (CAF+PRF) or the control (CAF+SCTG) groups with the use of computer-generated randomization table after assessment of clinical parameters at baseline.

Procedure: Control groups

Interventions

test groupsPROCEDURE

At the test sites, the previously prepared PRF was positioned over the recession defects, the coronal margin of the PRF was placed at the CEJ

Also known as: PRF groups
Test groups.
Control groupsPROCEDURE

Split-full-split thickness flap incisions were performed in a coronal-apical direction. The papillae adjacent to the involved tooth were de-epithelialized to create a connective tissue bed. The gingival flap was repositioned without tension, with its margin located on the enamel, on the test and control sides. It was held in that position with 5-0 resoble sutures

Also known as: Connective tissue graft groups
Control groups.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • non smoking,
  • similar bilateral Miller Class I or II20 localized gingival recessions at least ≥3 mm, located on incisors, canines or premolars on both jaws,
  • identifiable cemento-enamel junction (CEJ),
  • age ≥18 years,
  • presence of tooth vitality and absence of restorations and superficial caries in the area to be treated,
  • no periodontal surgical treatment on the involved sites,
  • sufficient palatal donor tissue at least ≥2.5 mm thickness for the indicated SCTG

You may not qualify if:

  • Patients in a pregnancy or lactation period or with self-reported history of antibiotic medication within 6 months
  • Molar, mobile or fully restorated teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NEU Dental School

Konya, 42060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • ELİF ÖNCÜ, PhD

    NECMETTİN ERBAKAN UNIVERSITY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist.Prof.Dr.

Study Record Dates

First Submitted

December 13, 2014

First Posted

January 12, 2015

Study Start

January 1, 2014

Primary Completion

January 1, 2014

Study Completion

August 1, 2014

Last Updated

January 12, 2015

Record last verified: 2015-01

Locations

TU(1)