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

Primary Purpose

Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GIC
Biodentine
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring gingiva, plaque, pocket depth

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    GIC filling

    Biodentine filling

    Arm 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

    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.

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    January 6, 2018
    Last Updated
    January 25, 2018
    Sponsor
    Jordan University of Science and Technology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03418246
    Brief Title
    Cervical Carious Lesions Restored With Calcium Silicate Based Cement (Biodentine) Compared With Glass-ionomer Cement
    Official Title
    Gingival Health Around Cervical Carious Lesions Restored With Calcium Silicate Based Cement (Biodentine) Compared With Glass-ionomer Cement: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 3, 2015 (Actual)
    Primary Completion Date
    June 30, 2015 (Actual)
    Study Completion Date
    December 28, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Jordan University of Science and Technology

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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)
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingivitis
    Keywords
    gingiva, plaque, pocket depth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantInvestigator
    Masking Description
    Investigator and participants are blinded to restoration used.
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GIC filling
    Arm Type
    Sham Comparator
    Arm 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
    Arm Title
    Biodentine filling
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    GIC
    Intervention Description
    tooth colored filling
    Intervention Type
    Device
    Intervention Name(s)
    Biodentine
    Other Intervention Name(s)
    Calcium Cilicate
    Intervention Description
    White filling -Biodentine
    Primary Outcome Measure Information:
    Title
    Changes in Gingival index around Cervical Carious Lesions Restored with Calcium Silicate Based Cement (Biodentine™) Compared with Glass-Ionomer Cement;
    Description
    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
    Time Frame
    6 months
    Title
    Changes in Plaque accumulation around Cervical Carious Lesions Restored with Calcium
    Description
    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
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Changes in Pocket Depth around Cervical Carious Lesions Restored with Calcium
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rola Al Habashneh, ABP
    Organizational Affiliation
    JUST
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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