Clinical trial NCT01814592: Comparison Between Two Coronally Positioned Flap With Connective Tissue
Official title: Comparison of Two Bilaminar Techniques for Root Covering of Miller´s Recessions Class I and II: A Blind, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gingival Recession
Periodontal Atrophy
Keywords: coronally positioned flap
connective tissue
gingival margin
gingival recession/ treatment
gingival recession/ surgery
subepithelial connective tissue graft
randomized controlled clinical trial
surgical flaps
Treatment outcome
Lead sponsor: Universidad El Bosque, Bogotá
Sponsor class: OTHER
First posted: 2013-03-20
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 \<200.
  * 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

Primary outcomes:
measure: 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"
timeFrame: one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)
Secondary outcomes:
measure: Assess the proportion of root coverage
timeFrame: one month (plus or minus 2 days), Three months (plus or minus 3 days) and six month (plus or minus 5 days)
measure: Clinical attachment level, width of keratinized tissue and the position of the mucogingival junction following root coverage procedures
timeFrame: one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days)
Other outcomes:
measure: Assess the frequency of adverse events
timeFrame: 0 hours (intrasurgical), 1-24 hours (immediate postoperative), 25 hours to 6 days (mediate postoperative) and 7 or more days (late postoperative)
Locations:
city: Bogotá, D. C.
country: Colombia
facility: Universidad El Bosque
Study officials:
affiliation: Universidad El bosque- UNIECLO
name: Sergio I Losada Amaya, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad El Bosque- UNIECLO
name: Jaime A Marquez Cristo, Professor
role: STUDY_CHAIR
affiliation: Universidad El Bosque- UNIECLO
name: Miguel F Vargas del Campo, Professor
role: STUDY_CHAIR
affiliation: Universidad El Bosque- UNIECLO
name: Silie S Arboleda Salaiman, Professor
role: STUDY_CHAIR
affiliation: Universidad El Bosque- UNIECLO
name: Maria I Pardo Silva, Professor
role: STUDY_DIRECTOR
References: