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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03418246
• Other study ID #: JordanUST5
• Status: Completed
• Phase: N/A
• First received: January 6, 2018
• Last updated: January 25, 2018
• Start date: January 3, 2015
• Est. completion date: December 28, 2015

Study information

• Verified date: January 2018
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 28, 2015
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Gingivitis

Intervention

Device:
• GIC
tooth colored filling
• Biodentine
White filling -Biodentine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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