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

NCT03418246 | Completed DMC

• 1 other identifier: JordanUST5
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Gingivitis

Keywords

gingiva; plaque; pocket depth

Outcome Measures

Primary Outcomes (2)

• 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 1. 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. 2. 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. 3. 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 Outcomes (1)

• Changes in Pocket Depth around Cervical Carious Lesions Restored with Calcium

  6 months

Study Arms (2)

GIC filling

SHAM COMPARATOR

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

Biodentine filling

EXPERIMENTAL

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

Interventions

GIC DEVICE

tooth colored filling

GIC filling

Biodentine DEVICE

White filling -Biodentine

Also known as: Calcium Cilicate

Biodentine filling

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Rola Al Habashneh, ABP

  JUST

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigator and participants are blinded to restoration used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2018
• First Posted: February 1, 2018
• Study Start: January 3, 2015
• Primary Completion: June 30, 2015
• Study Completion: December 28, 2015
• Last Updated: February 1, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share