Treatment of Gingival Recession-type Defects Using Different Restorative Materials

NCT02788266 | Completed

• 1 other identifier: 25901600-7587
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: The aim of this study was to evaluate the treatment of multiple gingival recessions associated with non-carious cervical lesions (NCCL) using a modified coronally advanced flap in combination with a sub-epithelial connective tissue graft (SCTG) on restored root surfaces. Methods: Twenty-three systemically healthy subjects, who were positive for the presence of three cervical lesions associated with gingival recessions in three different adjacent teeth, were enrolled in the study. The NCCL were each restored prior to surgery by using one of three different materials: composite resin (group 1), resin-modified glass ionomer cement (group 2) or giomer (group 3). The defects were treated with SCTG. Clinical measurements, including plaque index (PI), bleeding on probing (BOP), relative recession height (rRH), probing depth (PD), cervical lesion height (CLH), relative clinical attachment level (rCAL), keratinized tissue height (KTH), keratinized tissue thickness (KTT), percentage of root coverage (RC), and percentage of cervical lesion height coverage (CLHC) were recorded at baseline, 3 and 6 months, and 1 year postoperatively.

Conditions

Gingival Recession; Tooth Abrasion

Keywords

Cervical lesion; gingival recession; restorative materials

Outcome Measures

Primary Outcomes (1)

• relative gingival recession height

  measured as distance from the most apical point of gingival margin to the incisional border of the tooth

  one year post-op

Secondary Outcomes (1)

• keratinized tissue width

  one year

Study Arms (3)

connective tissue graft+composite resin

ACTIVE COMPARATOR

connective tissue graft plus composite resin

Procedure: connective tissue graft+composite resin

connective tissue graft+ glass ionomer

ACTIVE COMPARATOR

connective tissue graft plus resin modified glass ionomer cement

Procedure: connective tissue graft+ glass ionomer

connective tissue graft+giomer

ACTIVE COMPARATOR

connective tissue graft plus giomer

Procedure: connective tissue graft+giomer

Interventions

connective tissue graft+composite resin PROCEDURE

treatment of gingival recession associated with cervical lesions with sub epithelial connective tissue graft plus composite resin

connective tissue graft+composite resin

connective tissue graft+ glass ionomer PROCEDURE

treatment of gingival recession associated with cervical lesions with sub epithelial connective tissue graft plus resin modified glass ionomer cement

connective tissue graft+ glass ionomer

connective tissue graft+giomer PROCEDURE

treatment of gingival recession associated with cervical lesions with sub epithelial connective tissue graft plus giomer

connective tissue graft+giomer

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive for the presence of three cervical lesions associated with multiple gingival recessions in three different adjacent teeth excluding molars;
• Miller Class I gingival recession defect (≥2 and ≤5 mm) associated with buccal NCCL (lesion depth 1-2 mm);
• Non-smoker;
• Systemically and periodontally healthy;
• Not taking medications known to interfere with periodontal tissue health or healing;
• Probing depth (PD)≤3 mm;
• Presence of ≥1 mm highly keratinized tissue apical to the root exposure, and presence of ≥0.8 mm-thick gingival tissue;
• Absence of non-vital teeth, caries or restorations on cervical areas, severe occlusal interferences and previous surgery in the area.

You may not qualify if:

• inflammatory periodontal disease; previous surgical attempt to correct gingival recession; systemic disease or severe immune deficiency; coagulation defect or current anticoagulation treatment; addiction to drugs; inability or unwillingness to complete the trial; lack of linguistic skills; psychiatric disorders; refusal to sign the informed consent form; pregnancy; molar or premolar teeth with furcation involvement.

Sponsors & Collaborators

• Gazi University: lead

MeSH Terms

Conditions

Gingival Recession; Tooth Abrasion

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Tooth Wear; Tooth Diseases

Study Officials

• gonen ozcan, Ph D

  Prof.dr.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 2, 2016
• Study Start: December 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 2, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share