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

Jordan University of Science and Technology

Status: Completed

Conditions: Gingivitis

Treatments: Device: GIC; Device: Biodentine

Study type: Interventional

Funder types: Other

Identifiers

NCT03418246

JordanUST5

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 28 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

GIC filling

Sham Comparator group

Description:

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

Treatment:

Device: GIC

Biodentine filling

Experimental group

Description:

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.

Treatment:

Device: Biodentine