Comparison Between Two Coronally Positioned Flap With Connective Tissue

NCT01814592 | Unknown Phase 2 DMC

• 1 other identifier: PCI-2012-359
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• 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)

Other Outcomes (1)

• 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)

Study Arms (2)

coronally mucosal thickness flap

EXPERIMENTAL

coronally mucosal thickness flap plus connective tissue graft for root coverage (subepithelial connective tissue graft)

Procedure: coronally mucosal thickness flap

coronally partial thickness flap

ACTIVE COMPARATOR

coronally partial thickness flap plus connective tissue for root coverage (subepithelial connective tissue graft)

Procedure: coronally partial thickness flap plus connective tissue

Interventions

coronally partial thickness flap plus connective tissue PROCEDURE

The design of the flap will be performed according to the technique described by de Sanctis and Zucchelli 2007.

Also known as: subepithelial connective tissue graft, coronally positioned flap

coronally partial thickness flap

coronally mucosal thickness flap PROCEDURE

The design of the flap will be performed according to the technique described by Greenwell H, Vance G, Munninger B and Johnston H.

Also known as: superficial-layer split-tihickness flap

coronally mucosal thickness flap

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad El Bosque, Bogotá: lead

Study Sites (1)

Universidad El Bosque

Bogotá, D. C., Bogotá, D. C., 110121, Colombia

Location

MeSH Terms

Conditions

Gingival Recession; Periodontal Atrophy

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Sergio I Losada Amaya, Professor

  Universidad El bosque- UNIECLO

  PRINCIPAL INVESTIGATOR

• Jaime A Marquez Cristo, Professor

  Universidad El Bosque- UNIECLO

  STUDY CHAIR

• Miguel F Vargas del Campo, Professor

  Universidad El Bosque- UNIECLO

  STUDY CHAIR

• Silie S Arboleda Salaiman, Professor

  Universidad El Bosque- UNIECLO

  STUDY CHAIR

• Maria I Pardo Silva, Professor

  Universidad El Bosque- UNIECLO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, DDS, specialist in periodontics and oral medicine

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 20, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 26, 2013

Record last verified: 2013-03

Locations

CO (1)