NCT04093674

Brief Summary

This split-mouth randomized clinical trial compared two different types of subepithelial connective tissue grafts (SCTG) considering clinical parameters and patient-centered outcomes in patients with bilateral RT 1 multiple gingival recessions after 6 months postoperatively. 21 patients with 84 sites were surgically treated with coronally advanced flap (CAF) associated with SCTG harvested by: double blade scalpel (DBS) and de-epithelized (DE) SCTG. Periodontal clinical parameters and aesthetics were evaluated by a calibrated periodontist at baseline and after 6 months. Patient-centered outcomes related to pain/discomfort and aesthetics were assessed with Visual Analogue Scale (VAS) after 7 days and 6 months, respectively. Gingival blood flows were analyzed by Laser Doppler flowmetry (FLD) at baseline and 2, 7 and 14 days postoperatively.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

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

February 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

September 10, 2019

Last Update Submit

September 16, 2019

Conditions

Gingival Recession, Generalized

Keywords

connective tissuerandomized controlled trialgingival recessionpatient outcome assessment

Outcome Measures

Primary Outcomes (1)

  • Percentage of root coverage based on Recession depth at baseline and after 6 months

    Distance in millimeters of cemento-enamel junction (CEJ) to gingival margin measured at the midbuccal aspect of the tooth

    6 months

Secondary Outcomes (8)

  • Variation on: Recession width (RW) comparing baseline measurements to 6 months.

    6 months

  • Variation on: Probing depth (PD) comparing baseline measurements to 6 months.

    6 months

  • Variation on: Clinical attachment level (CAL) comparing baseline measurements to 6 months.

    6 months

  • Variation on: Keratinized tissue width (KTW) comparing baseline measurements to 6 months.

    6 months

  • Variation on: Keratinized tissue thickness (KTT) comparing baseline measurements to 6 months.

    6 months

  • +3 more secondary outcomes

Other Outcomes (1)

  • Laser doppler flowmetry

    14 days

Study Arms (3)

Clinical evaluation

EXPERIMENTAL

Clinical periodontal parameters

Procedure: de-epithelized (DE) SCTG

Laser Doppler Flowmetry

EXPERIMENTAL

Laser Doppler Flowmetry evaluation

Procedure: de-epithelized (DE) SCTG

Patient centered outcomes

EXPERIMENTAL

Pain and discomfort/ Esthetics

Procedure: de-epithelized (DE) SCTG

Interventions

de-epithelized (DE) SCTGPROCEDURE

subepithelial connective tissue grafts

Also known as: double blade scalpel (DBS) SCTG
Clinical evaluationLaser Doppler FlowmetryPatient centered outcomes

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • systemically healthy patients between 18 and 70 years
  • clinical diagnosis of bilateral multiple gingival recessions, recession type (RT) 1 (Cairo et al. 2011) with at least one gingival recession ≥ 2 mm on each side, including canines and premolars.

You may not qualify if:

  • abnormal teeth position
  • smokers, pregnant or nursing women
  • parafunctional habits
  • plaque and bleeding indexes (Ainamo \& Bay, 1975) above 20%
  • previous periodontal surgeries on selected sites.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.

    PMID: 24640997BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Mariana S Ragghianti Zangrando, Professor

    Bauru School of Dentistry-University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Split mouth
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistent Professor

Study Record Dates

First Submitted

September 10, 2019

First Posted

September 18, 2019

Study Start

February 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2019

Last Updated

September 18, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share