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Completed

NCT Number: NCT03418246

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

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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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Periodontal Diseases Plaque, Amyloid Stomatognathic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GIC

Device

tooth colored filling

Biodentine

Device

White filling -Biodentine

Other names: Calcium Cilicate

Primary outcomes

  1. Changes in Gingival index around Cervical Carious Lesions Restored with Calcium Silicate Based Cement (Biodentine™) Compared with Glass-Ionomer Cement;

    Time frame: 6 months

    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

  2. Changes in Plaque accumulation around Cervical Carious Lesions Restored with Calcium

    Time frame: 6 months

    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

Secondary outcomes

  1. Changes in Pocket Depth around Cervical Carious Lesions Restored with Calcium

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2018
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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