Cervical Restorations Placed Under Two Isolation Methods
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|ClinicalTrials.gov Identifier: NCT01506830|
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : February 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-carious Cervical Lesions||Procedure: Relative isolation with cotton rolls Procedure: Absolute isolation with rubber dam||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Influence of Operatory Field Isolation Techniques on the Clinical Performance of Class V Restorations|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||December 2011|
Active Comparator: Absolute isolation
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.
Procedure: 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.
Experimental: Relative isolation
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
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
- retention of restorations [ Time Frame: up to 72 months ]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.
- Restorations marginal staining [ Time Frame: up to 72 months ]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.
- Periodontal condition of restored sites [ Time Frame: 6, 12, 24, 48 and 72 months after restorations' placement ]The periodontal condition of restored sites is evaluated based on the presence of supragingival plaque, gingival marginal bleeding, probing depth, and relative gingival recession.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506830
|Federal University of Pelotas - School of Dentistry|
|Pelotas, RS, Brazil, 96015560|
|Study Chair:||Alexandre S Masotti, PhD||Federal University of Pelotas|
|Principal Investigator:||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|