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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01814592
Other study ID # PCI-2012-359
Secondary ID
Status Enrolling by invitation
Phase Phase 2
First received March 11, 2013
Last updated March 23, 2013
Start date March 2013
Est. completion date August 2014

Study information

Verified date March 2013
Source Universidad El Bosque, Bogotá
Contact n/a
Is FDA regulated No
Health authority Colombia: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

This is a blind, randomized controlled clinical trial.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 72
Est. completion date August 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
coronally partial thickness flap plus connective tissue
The design of the flap will be performed according to the technique described by de Sanctis and Zucchelli 2007.
coronally mucosal thickness flap
The design of the flap will be performed according to the technique described by Greenwell H, Vance G, Munninger B and Johnston H.

Locations

Country Name City State
Colombia Universidad El Bosque Bogotá, D. C.

Sponsors (1)

Lead Sponsor Collaborator
Universidad El Bosque, Bogotá

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Other Assess the frequency of adverse events 0 hours (intrasurgical), 1-24 hours (immediate postoperative), 25 hours to 6 days (mediate postoperative) and 7 or more days (late postoperative) Yes
Primary 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" one month (plus or minus 2 days), three months (plus or minus 3 days) and six months (plus or minus 5 days) Yes
Secondary 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) Yes
Secondary 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) Yes
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