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Clinical Trials/NCT01814592
NCT01814592UnknownPhase 2

Comparison of Two Bilaminar Techniques for Root Covering of Miller´s Recessions Class I and II: A Blind, Randomized Controlled Clinical Trial

Universidad El Bosque, Bogotá2 sites in 1 country72 target enrollmentStarted: March 1, 2013Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Sponsor
Enrollment
72
Locations
2
Primary Endpoint
Assess percentage of total root coverage between two subepithelial conective tissue graft technique for covering Class I and II Miller recessions patients attending at dental clinics of "Universidad El Bosque"
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The aim of this study is to evaluate the effectiveness of total root coverage between two coronally positioned flap technique in Miller recession Class I and II, in patients attending at "Universidad El Bosque" dental school clinics.

Detailed Description

This is a blind, randomized controlled clinical trial.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Class I and II Miller recessions showing a recession depth ≥ 2 mm.
  • •Recessions isolated and / or maximum continuous two teeth.
  • •Recessions in incisors, canines and premolars
  • •Patients 20 to 60 years old.

Exclusion Criteria

  • •Systemic compromise, that contraindicates any periodontal surgical procedure.
  • •Warfarin medication.
  • •Uncontrolled diabetes mellitus with glycosylated hemoglobin ≥ 8
  • •Chronic steroid therapy (dose of 7.5 mg/ day for more than 14 days)
  • •HIV-AIDS infection with CD4 counts <
  • •Immunosuppression.
  • •Recessions molars not be taken into account in the study.
  • •Patients who have used antibiotics one month prior to the surgical procedure.
  • •Pregnancy.
  • •Active smoker.
  • •Patients with a history of periodontal surgery at the recession area that has taken place in the last three months.
  • •Severe dental malposition, teeth rotation, versions teeth root coverage that contraindicates surgery.
  • •Non carious cervical lesions or caries where is not visible the cemento- enamel junction (CEJ).
  • •Active inflammation that contraindicates surgical procedure of the recession.
  • •Active Orthodontics

Outcomes

Primary Outcomes

Assess percentage of total root coverage between two subepithelial conective tissue graft technique for covering Class I and II Miller recessions patients attending at dental clinics of "Universidad El Bosque"

Time Frame: one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)

Secondary Outcomes

  • Assess the proportion of root coverage(one month (plus or minus 2 days), Three months (plus or minus 3 days) and six month (plus or minus 5 days))
  • Clinical attachment level, width of keratinized tissue and the position of the mucogingival junction following root coverage procedures(one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days))

Investigators

Sponsor
Universidad El Bosque, Bogotá
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sergio Iván Losada Amaya

Professor, DDS, specialist in periodontics and oral medicine

Universidad El Bosque, Bogotá

Study Sites (2)

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