Cervical Restorations Placed Under Two Isolation Methods

Non-carious Cervical Lesions Clinical Trial

Official title:

Influence of Operatory Field Isolation Techniques on the Clinical Performance of Class V Restorations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506830
• Other study ID #: UFPEL-PPGO0012
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 30, 2011
• Last updated: February 23, 2016
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2016
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

During restorative procedures, different isolation methods of the operative field can be used to promote moisture control and retraction of the gingival tissues. The aim of the present clinical trial is to evaluate the effects of two isolation techniques on the clinical performance of Class V restorations, as well on the periodontal conditions of restored sites. Patients presenting at least two noncarious cervical lesions (NCLs) will be enrolled in this study. The NCLs will be randomized into the following groups: (1) isolation performed with rubber dam and gingival retraction clamp and (2) isolation provided with cotton rolls and gingival retraction cord. Both techniques will be used with a saliva suction device. All restorative procedures were performed using a self-etching adhesive system and a nanofilled composite resin according to the manufacturer's instructions. The clinical performance of restorations will be recorded in terms of fracture and retention of restoration, marginal adaptation, marginal staining, postoperative hypersensitivity, and preservation of tooth vitality at 1 week, 6 months, 12, 24 and 72 months after placement. The periodontal condition of restored sites will be evaluated based on the presence of supragingival plaque, gingival marginal bleeding, probing depth, and relative gingival recession.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• more than one cervical lesion

• lesions whose apical limit located above the gingival margin

• lesions with at least 1 mm of depth

• vital permanent incisors, canines, or premolars

Exclusion Criteria:

• smoking habits

• severe systemic diseases

• active orthodontic treatment

• malocclusion (Angle Class II or Class III)

• less than 20 natural teeth in mouth

• absent of antagonist tooth

• wear facets over more than 50% of the incisal/occlusion surface as a result of tooth attrition

• or restorations in the area to be treated

• full-mouth visible plaque index (VPI) or full-mouth gingival bleeding index (GBI) more than 20%

• probing depth (PD) and clinical attachment loss (CAL) values exceeding 4 mm with bleeding on probing (BOP)

• unwillingness to return for follow-ups or refuse to participate

Study Design

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

Related Conditions & MeSH terms

• Non-carious Cervical Lesions

Intervention

Procedure:
• Relative isolation with cotton rolls
Cotton roll group: Moisture control was provided using a labial retractor, cotton rolls and gingival retraction cord placed into the gingival sulcus
• Absolute isolation with rubber dam
Rubber dam group: Moisture control was provided by a rubber dam and a gingival retraction clamp placed in the cervical area of the tooth.

Locations

Country	Name	City	State
Brazil	Federal University of Pelotas - School of Dentistry	Pelotas	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	retention of restorations	Retention of restorations is measured by clinical examination, where each placed restoration is checked and scored as present, partially lost or lost at the recalls.	up to 72 months	No
Primary	Restorations marginal staining	Restorations are checked during recalls regarding the marginal staining and scored as clinically ideal, clinically acceptable; presence of small ditching; presence of extensive marginal ditching and need for repair /replacement.	up to 72 months	No
Secondary	Periodontal condition of restored sites	The periodontal condition of restored sites is evaluated based on the presence of supragingival plaque, gingival marginal bleeding, probing depth, and relative gingival recession.	6, 12, 24, 48 and 72 months after restorations' placement	No