Cervical Carious Lesions Restored With Calcium Silicate Based Cement (Biodentine) Compared With Glass-ionomer Cement
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|ClinicalTrials.gov Identifier: NCT03418246|
Recruitment Status : Completed
First Posted : February 1, 2018
Last Update Posted : February 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gingivitis||Device: GIC Device: Biodentine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|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.|
|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|
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
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.
White filling -Biodentine
Other Name: Calcium Cilicate
- 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
- 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
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
- 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.
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
|Study Director:||Rola Al Habashneh, ABP||JUST|