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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Absolute isolation | Active Comparator | Absolute isolation of the operatory field with rubber dam: Moisture control is provided by a rubber dam and a gingival retraction clamp placed in the cervical area of the tooth. |
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| Relative isolation | Experimental | Relative isolation of the operatory field with cotton rolls: Moisture control was provided using a labial retractor, cotton rolls and gingival retraction cord placed into the gingival sulcus |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relative isolation with cotton rolls | Procedure | Cotton roll group: Moisture control was provided using a labial retractor, cotton rolls and gingival retraction cord placed into the gingival sulcus |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre S Masotti, PhD | Federal University of Pelotas | Study Chair |
| Fernanda OB Corrêa, PhD | Federal University of Pelotas | Principal Investigator |
| Silvia T Fontes, PhD | Federal University of Pelotas | Principal Investigator |
| Maximiliano S Cenci, PhD | Federal University of Pelotas | Principal Investigator |
| Patricia S Jardim, PhD | Federal University of Pelotas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Pelotas - School of Dentistry | Pelotas | Rio Grande do Sul | 96015560 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33385534 | Derived | 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. |
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| ID | Term |
|---|---|
| D016733 | Rubber Dams |
| ID | Term |
|---|---|
| D003748 | Dental Equipment |
| D003813 | Dentistry |
| D004864 | Equipment and Supplies |
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| Absolute isolation with rubber dam | Procedure | Rubber dam group: Moisture control was provided by a rubber dam and a gingival retraction clamp placed in the cervical area of the tooth. |
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