NCT02479633

Brief Summary

Background: The aim of present clinical study was to evaluate the predictive values of baseline inter-dental papilla height (IPH), avascular exposed root surface area (AERSA) and inter-dental clinical attachment loss (CAL) measurements on complete root coverage (CRC) of single gingival recession (GR) defects treated with coronally advanced flap and connective tissue graft technique (CAF+CTG). Material and Methods: The study group included 65 females and 57 males, aged between 20 and 42 years. A total of 122 recession defects without CAL and with an amount of CAL equal or smaller to the buccal CAL , located at upper and lower incisors and canines were treated with CAF+CTG. IPH, AERSA and CAL parameters were analyzed for possible correlation with CRC after 6 months.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

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, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

June 17, 2015

Last Update Submit

June 19, 2015

Conditions

Keywords

prognostic factors

Outcome Measures

Primary Outcomes (1)

  • values of baseline interdental papill height

    in mm

    1 year

Secondary Outcomes (2)

  • avascular exposed root surface area

    1 year

  • interdental clinical attachment level

    1 year

Study Arms (2)

gingival recession type 1

OTHER

recession defects without CAL intervention:Coronally advanced flap with connective tissue graft

Other: Coronally advanced flap with connective tissue graft

gingival recession type 2

OTHER

gingival recession with an amount of CAL equal or smaller to the buccal CAL. Intervention: Coronally advanced flap with connective tissue graft

Other: Coronally advanced flap with connective tissue graft

Interventions

Two oblique, divergent releasing incisions extending beyond the mucogingival junction were performed. An intra-sulcular incision was performed at the buccal aspect of the involved tooth. Subsequently, a partial-thickness flap was raised beyond the MGJ. The papilla adjacent to the involved tooth were then de-epithelialized. The CTG was harvested using a single incision approach from the palate. The graft was positioned on the instrumented root surface immediately apical of the CEJ and then stabilized using a sling compressive crossing suture. The flap was coronally displaced 1-2 mm above the CEJ. A sling suture was placed to stabilize the flap in a coronal position, followed by interrupted sutures on the releasing incisions with an apico-coronal direction.

Also known as: CAF+CTG
gingival recession type 1gingival recession type 2

Eligibility Criteria

Age20 Years - 42 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Presence of isolated RT1 and RT2 class gingival recessions with an AERSA ˃9mm2 on upper and lower incisors,
  • Presence of identifiable cemento-enamel junction (CEJ); presence of a step ≤1mm at the CEJ level and/or the presence of a root abrasion, but with an identifiable CEJ,
  • Full-mouth plaque score and Full-mouth bleeding score of \<15%,
  • No occlusal interferences;

You may not qualify if:

  • Patients with a history of periodontitis or abscess formation,
  • Mucogingival or periodontal surgery at the experimental site in the last 1 year,
  • Presence of systemic disease or taking medication known to interfere with periodontal tissue health,
  • Smokers, pregnant patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Onur Ozcelik, Prof. Dr

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 24, 2015

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

June 1, 2014

Last Updated

June 24, 2015

Record last verified: 2015-06