Clinical trial NCT01506830: Cervical Restorations Placed Under Two Isolation Methods
Official title: Influence of Operatory Field Isolation Techniques on the Clinical Performance of Class V Restorations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Non-carious Cervical Lesions
Keywords: Adhesives.
Composites.
Noncarious cervical lesions.
Clinical performance.
Treatment
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2012-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: retention of restorations
timeFrame: up to 72 months
measure: Restorations marginal staining
timeFrame: up to 72 months
Secondary outcomes:
measure: Periodontal condition of restored sites
timeFrame: 6, 12, 24, 48 and 72 months after restorations' placement
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas - School of Dentistry
state: RS
Study officials:
affiliation: Federal University of Pelotas
name: Alexandre S Masotti, PhD
role: STUDY_CHAIR
affiliation: Federal University of Pelotas
name: Fernanda OB Corrêa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Pelotas
name: Silvia T Fontes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Pelotas
name: Maximiliano S Cenci, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Pelotas
name: Patricia S Jardim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Favetti M, Montagner AF, Fontes ST, Martins TM, Masotti AS, Jardim PDS, Correa FOB, Cenci MS, Muniz FWMG. Effects of cervical restorations on the periodontal tissues: 5-year follow-up results of a randomized clinical trial. J Dent. 2021 Mar;106:103571. doi: 10.1016/j.jdent.2020.103571. Epub 2020 Dec 29.