Deep Caries Clinical Trial
Official title:
Clinical, Radiographic and Histological Evaluation of Three Different Pulp Capping Materials in Indirect Pulp Treatment of Primary Teeth: A Randomized Clinical Trial
Verified date | February 2020 |
Source | Izmir Katip Celebi University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this randomized, controlled, three-arm parallel-group, double-blinded clinical
trial was to evaluate the clinical, radiographic, and histopathological success of three
different pulp-capping materials in one-stage indirect pulp treatment of primary teeth.
The study included a total of 109 patients aged 5-9 years who had primary teeth with deep
carious lesions with or symptoms of irreversible pulpitis. The teeth were divided into three
groups according to the pulp-capping agents: (I) Calcium hydroxide (Ca[OH]2) (control group)
(n=36), (II) bioactive tricalcium silicate (Biodentine) (n=37), and (III) resin-based
tricalcium silicate (TheraCal LC) (n=36). All the teeth were evaluated clinically and
radiographically at postoperative months 6, 12, 18, and 24. A total of 23 primary mandibular
second molars that were in their regular exfoliation period (24-40 months) were extracted and
fixed in 10% formaldehyde solution. The specimens were evaluated histologically to assess the
integrity of the odontoblastic layer, tertiary dentin formation and the quality of the dentin
formed, severity of pulpitis, and other pulpal changes.
Status | Completed |
Enrollment | 109 |
Est. completion date | July 7, 2018 |
Est. primary completion date | September 15, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 9 Years |
Eligibility |
Inclusion Criteria: - Previously untreated, vital and asymptomatic lower primary molars with deep caries lesions considered likely to result in pulp exposure if they were treated by a single and terminal excavation - Positive pulp sensibility tested by an electric pulp tester and cold stimulation, - Mild discomfort from chemical and thermal stimuli, - Cooperative children and parents willing to follow the instructions and report for follow-up. Exclusion Criteria: - Signs of irreversible pulpitis (spontaneous pain, prolonged pain response etc.) - The presence of percussion or palpation sensitivity, pathological mobility, or infection symptoms like fistula or abscess or discoloration in the clinical examination, - Absence of normal lamina dura and periodontal range, presence of lesion, internal or external resorption or calcification in or around the root in the radiological examination, - Children with special health care needs. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Izmir Katip Celebi University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical success rate of indirect pulp treatment | Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure. | Change of clinical success from Baseline at 6 month | |
Primary | Clinical success rate of indirect pulp treatment | Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure. | Change of clinical success from baseline to 12 month | |
Primary | Clinical success rate of indirect pulp treatment | Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure. | Change of clinical success from baseline to 18 month | |
Primary | Clinical success rate of indirect pulp treatment | Treatment is considered a clinical failure if one or more of the following signs are observed: Presence of tenderness to percussion or palpation, spontaneous pain or prolonged pain response, discoloration, infectious symptoms such as fistula or abscess, and pathological mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure. | Change of clinical success from baseline to 24 month | |
Primary | Radiographic success rate of indirect pulp treatment | For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure. | Change of radiographic success from baseline to 6 month | |
Primary | Radiographic success rate of indirect pulp treatment | For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure. | Change of radiographic success from baseline to 12 month | |
Primary | Radiographic success rate of indirect pulp treatment | For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure. | Change of radiographic success from baseline to 18 month | |
Primary | Radiographic success rate of indirect pulp treatment | For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: lesions in the furcation or periapical regions, internal or external root resorption, and thickening of the periodontal spaces. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure. | Change of radiographic success from baseline to 24 month | |
Secondary | Histological success rate of indirect pulp treatment | For histologic evaluation, the treatment is rated as a failure when one or more of the following signs are present: absent of the integrity of the odontoblastic layer, absent of tertiary dentin formation, presence of pulpitis, presence of fibrosis and dystrophic calcification. The treatment is regarded successful if histologic evaluation does not indicate any signs of failure. | up to 40 months (the teeth were extracted in regular exfoliation period (in which the underlying permanent tooth germ had completed 2/3 of root formation). |
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