NCT04109794

Brief Summary

42 patients were treated either with E-CTG (N=20) or SCAF (N=22). The recordings included clinician-based (recession depth, recession width, probing depth, clinical attachment level, keratinized tissue width, tissue thickness, clinical attachment gain (CAG), root coverage (RC), keratinized tissue change (KTC)) and patient-based (wound healing index (WHI), dentine hypersensitivity (DH), tissue appearance, patient expectations and aesthetics) parameters that were taken at baseline, T1 (sixth week), T2 (sixth month) and T3 (first year).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

September 26, 2019

Last Update Submit

September 27, 2019

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (4)

  • recession depth

    Distance between CEJ and GM

    baseline

  • recession depth

    Distance between CEJ and GM

    6 weeks

  • recession depth

    Distance between CEJ and GM

    6 months

  • recession depth

    Distance between CEJ and GM

    12 months

Secondary Outcomes (16)

  • recession width

    baseline

  • recession width

    6 weeks

  • recession width

    6 months

  • recession width

    12 months

  • probing depth

    baseline

  • +11 more secondary outcomes

Study Arms (2)

E-CTG

ACTIVE COMPARATOR

Envelope connective tissue graft

Procedure: E-CTG

SCAF

ACTIVE COMPARATOR

Semilunar connective tissue graft

Procedure: E-CTG

Interventions

E-CTGPROCEDURE

Envelope connective tissue graft

E-CTGSCAF

Eligibility Criteria

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

You may qualify if:

  • single Miller I GR defects ≤3mm at upper anterior or premolar teeth
  • systemically healthy
  • identifiable cemento-enamel junction (CEJ)
  • PD ≤3 mm

You may not qualify if:

  • periodontal surgery experience in the past two years
  • excessive contacts
  • mobility
  • caries
  • loss of vitality
  • smoking
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Evginer MS, Olgun E, Parlak HM, Dolgun AB, Keceli HG. Comparison of two techniques in gingival recession treatment: A randomized one-year clinical follow-up study. Dent Med Probl. 2022 Jan-Mar;59(1):121-130. doi: 10.17219/dmp/137621.

    PMID: 35394710DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 26, 2019

First Posted

September 30, 2019

Study Start

December 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

September 30, 2019

Record last verified: 2019-09