Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03418246
Recruitment Status : Completed
First Posted : February 1, 2018
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Rola Abdelraheem Alhabashneh, Jordan University of Science and Technology

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)

Condition or disease Intervention/treatment Phase
Gingivitis Device: GIC Device: Biodentine Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Masking Description: Investigator and participants are blinded to restoration used.
Primary Purpose: Treatment
Official Title: Gingival Health Around Cervical Carious Lesions Restored With Calcium Silicate Based Cement (Biodentine) Compared With Glass-ionomer Cement: A Randomized Clinical Trial
Actual Study Start Date : January 3, 2015
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : December 28, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: GIC filling

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
tooth colored filling

Experimental: Biodentine filling

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
White filling -Biodentine
Other Name: Calcium Cilicate




Primary Outcome Measures :
  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

    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


Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418246


Sponsors and Collaborators
Jordan University of Science and Technology
Investigators
Layout table for investigator information
Study Director: Rola Al Habashneh, ABP JUST

Layout table for additonal information
Responsible Party: Rola Abdelraheem Alhabashneh, Prof, Jordan University of Science and Technology
ClinicalTrials.gov Identifier: NCT03418246     History of Changes
Other Study ID Numbers: JordanUST5
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Rola Abdelraheem Alhabashneh, Jordan University of Science and Technology:
gingiva
plaque
pocket depth
Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Caries
Tooth Demineralization
Tooth Diseases
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents