Dental Caries Clinical Trial
Official title:
Selective Removal to Soft Dentine or Selective Removal to Firm Dentine for Deep Caries Lesions in Permanent Posterior Teeth: A Randomized Controlled Trial up to 5 Years
Verified date | June 2024 |
Source | Istanbul Medipol University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Removal of infected dentin contaminated with bacteria and remaining affected dentin detected as firm is the conventional strategy for the management of cavitated caries lesions. Recently, this strategy is termed as selective removal to firm dentin (SRFD) and seems to increase the potential risk of pulp exposure or loss of pulp vitality for deep caries lesions radiographically extending ¾ of dentin tissue. Alternatively, selective removal to soft dentine (SRSD) that refers to removal of caries tissue at the periphery of the cavity to firm dentin and remaining caries tissue detected as soft or leathery in proximity with the pulp might be a less invasive excavation method for deep caries lesions to maintain pulpal health. However, information on clinical advantages or disadvantages of SRSD and SRFD excavation methods is sparse and mostly rely on studies conducted for primary teeth. Moreover, clinical trials are needed to demonstrate the combined effect of carious removal strategies and calcium silicate-based materials. The aim of this study is comparison of clinical success rates of SRSD and SRFD techniques in posterior deep caries lesions. The primary outcome of the study is comparison of clinical success of SRSD and SRFD techniques by clinical and radiographic examination after 3 months, 6 months, 1 year and 2 years. The secondary outcome of the study is to investigate whether or not calcium silicate-based materials have an effect on the success rate of the treatment.
Status | Completed |
Enrollment | 141 |
Est. completion date | June 20, 2024 |
Est. primary completion date | March 3, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 65 Years |
Eligibility | Inclusion Criteria: - Deep primary active caries lesion extending at least 3/4 of dentin - No irreversible pulpitis symptoms - Positive response to electrical and cold pulp vitality tests - Good general health - No untreated periodontal disease - Acceptance to be included in study Exclusion Criteria: - Irreversible pulpitis symptoms - Negative response to electrical and cold pulp vitality tests - Radiographically periradicular pathology - Pregnancy - Teeth with non-carious lesions (attrition, erosion, abrasion or abfraction) - Patients planning bleaching or orthodontic treatment - Known allergy to study material |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medipol University, School of Dentistry | Istanbul |
Lead Sponsor | Collaborator |
---|---|
burcu gözetici | Istanbul Medipol University Hospital |
Turkey,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success (endodontic treatment required no/yes) | The primary outcome of the study will be success (i. e. not requiring root canal treatment intervention).
Pulp vitality (yes/no), pain on percussion or palpation (yes/no), presence of abscess or fistula (yes/no) will assessed clinically. Radiographically, periradicular pathology (yes/no), pathologic calcification or resorption (yes/no) will be assessed. |
60 months | |
Primary | Post-operative sensitivity (yes/no) | The second outcome of the study will depend on Patients' subjective assessment of the treatment (severe/moderate/no) | 60 months | |
Secondary | Dentin bridge formation | Whether or not placement of calcium silicate based material (Biodentine) has an extra benefit for dentin bridge formation (dentin bridge formation yes/no) | 60 months | |
Secondary | Restoration integrity | Restorations will be evaluated according to FDI World Dental Federation criteria (10). This instrument is composed of three dimensions (biological, functional and esthetic). Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome (1:excellent; 2:clinically good; 3:clinically satisfactory; 4:unsatisfactory but repairable; 5: replacement necessary).
Esthetic Properties: Surface Luster (1-5) Staining (1-5) Color match and translucency (1-5) Anatomical form (1-5) Functional Properties: Fracture of material and retention (1-5) Marginal adaptation (1-5) Occlusal wear (1-5) Approximal anatomical form (1-5) Radiographic examination (1-5) Patient's view (1-5) Biological Properties Recurrence of caries (1-5) Tooth integrity (1-5) |
60 months |
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