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CompletedNCT03418246Updated Feb 1, 2018

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

An interventional study of GIC and Biodentine in Gingivitis, sponsored by Jordan University of Science and Technology. Completed. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-02-01.

Sponsored by Jordan University of Science and Technology · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Gingivitis

Keywords

  • gingiva
  • plaque
  • pocket depth
03

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
28 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceGIC

    tooth colored filling

  • DeviceBiodentine

    White filling -Biodentine

    Also known as: Calcium Cilicate

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

  2. 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

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03418246
Lead sponsor
Jordan University of Science and Technology
Responsible party
Rola Abdelraheem Alhabashneh (Prof, Jordan University of Science and Technology) — Principal investigator
First posted
Feb 1, 2018
Start date
Jan 3, 2015
Primary completion
Jun 30, 2015
Completion
Dec 28, 2015
Last update
Feb 1, 2018

Study contacts

Rola Al Habashneh, ABP
study director · JUST

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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