Cervical Carious Lesions Restored With Calcium Silicate Based Cement (Biodentine) Compared With Glass-ionomer Cement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-03

Study Completion Date

2015-12-28

Brief Summary

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This study will test if applying calcium silicate cements (Biodentine) to restore cervical carious lesions might adversely affect the gingival health in comparison with conventionally used tooth colored material (GIC)

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Detailed Description

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The study will compare two different dental materials on dental lesions near the gum line. . The study will determine if one material is more effective in gingival health, after the placement of the two different dental materials.The oral hygiene and the gingival health of the restored teeth will be evaluated clinically at 1, 3 and 6-month intervals.

Conditions

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Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One group will be treated with a tooth colored filling that will be placed near the gum line (Glass Ionomer). The second group will be treated with Biodentine that will be placed near the gum line.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Investigator and participants are blinded to restoration used.

Study Groups

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GIC filling

Intervention/treatment One group will be treated with a tooth colored filling that will be placed near the gum line (Glass Ionomer).

Placebo Comparator: GIC

Participants will have a restoration placed with GIC in the lesion near the gum line. Device: GIC Application of a tooth colored filling in the cavitated dental lesion. Other Name: Resin modified glass ionomer

Group Type SHAM_COMPARATOR

GIC

Intervention Type DEVICE

tooth colored filling

Biodentine filling

Intervention/treatment The second group will be treated with Biodentine that will be placed near the gum line.Experimental: Biodentine

Participants will have a restoration placed with Biodentine in the lesion near the gum line. Device: Biodentine Application of a white colored filling in dental lesion.

Group Type EXPERIMENTAL

Biodentine

Intervention Type DEVICE

White filling -Biodentine

Interventions

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GIC

tooth colored filling

Intervention Type DEVICE

Biodentine

White filling -Biodentine

Intervention Type DEVICE

Other Intervention Names

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Calcium Cilicate

Eligibility Criteria

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Inclusion Criteria

1. good general health;
2. good oral hygiene; and
3. age range 18-60 years old.

Patients with the following criteria were excluded:

1. current smokers;
2. pregnant females;
3. or patient with periodontal diseases; and
4. those who had a history of poorly controlled diabetes, liver disease, malignancy, radiotherapy.

Exclusion Criteria

1. Pregnant women
2. Patients taking benzodiazepines, narcotics and multiple antidepressants for pain management not associated with the oral cavity
3. Patients requiring treatment for more than 5 decayed sites, periodontal disease and root canal therapy
4. Complicated medical history (\>4 concurrent treatment for systemic diseases)
5. Lesion \>1mm below the gum line

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No