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

Study Overview
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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)

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.

Official Title
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Gingival Health Around Cervical Carious Lesions Restored With Calcium Silicate Based Cement (Biodentine) Compared With Glass-ionomer Cement: A Randomized Clinical Trial

Conditions
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Gingivitis

Intervention / Treatment
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* Device: GIC
* Device: Biodentine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: good general health; good oral hygiene; and age range 18-60 years old. Patients with the following criteria were excluded: current smokers; pregnant females; or patient with periodontal diseases; and those who had a history of poorly controlled diabetes, liver disease, malignancy, radiotherapy. Exclusion Criteria: Pregnant women Patients taking benzodiazepines, narcotics and multiple antidepressants for pain management not associated with the oral cavity Patients requiring treatment for more than 5 decayed sites, periodontal disease and root canal therapy Complicated medical history (>4 concurrent treatment for systemic diseases) Lesion >1mm below the gum line

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: GIC filling<br>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 | Device: GIC<br>* tooth colored filling<br>|
| Experimental: Biodentine filling<br>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. | Device: Biodentine<br>* White filling -Biodentine<br>* Other names: Calcium Cilicate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Gingival index around Cervical Carious Lesions Restored with Calcium Silicate Based Cement (Biodentine™) Compared with Glass-Ionomer Cement; | Gingival health will be measured using the Loe -Silness gingival scoring Index (1963) which scores gingivitis on a numerical scale according to the following criteria: 0 = Absence of inflammation. 1 = Mild inflammation, slight change in color, slight edema, no bleeding on probing. 2 = Moderate inflammation, moderate glazing, redness, bleeding on probing. 3- Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous Gingival index will be evaluated at four sites (mesial, distal, buccal, and lingual) on each tooth | 6 months | 
| Changes in Plaque accumulation around Cervical Carious Lesions Restored with Calcium | detect plaque level around restorations Plaque index (PI) (Silness and Löe, 1964). Plaque levels was measured using the Plaque Index Silness and Loe in 1964 Score Criteria 0 No plaque A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye. But only by Using disclosing solution or by using probe. Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. Plaque index will be evaluated at four sites (mesial, distal, buccal, and lingual) on each tooth | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Pocket Depth around Cervical Carious Lesions Restored with Calcium | Probing depths (PD) will be measured at six sites (mesial, distal, and middle sites of the buccal and lingual sides) on each tooth using a Williams periodontal probe. PD will be measured from gingival margin to the base of the pocket. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gingiva, plaque, pocket depth