GingivitisNCT03418246
Cervical Carious Lesions Restored With Calcium Silicate Based Cement (Biodentine) Compared With Glass-ionomer Cement
A study testing GIC and Biodentine in people with Gingivitis, run by Jordan University of Science and Technology.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- GIC and Biodentine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2015to 28 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Gingival Health Around Cervical Carious Lesions Restored With Calcium Silicate Based Cement (Biodentine) Compared With Glass-ionomer Cement: A Randomized Clinical Trial
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.
- Conditions
- Gingivitis
- Being tested
- GIC, Biodentine
- Keywords
- gingiva, plaque, pocket depth
- Medical subject headings
- Gingivitis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GICDevice
tooth colored filling
BiodentineDevice
Also called Calcium Cilicate
White filling -Biodentine
| Study group | Role | What they receive |
|---|---|---|
| GIC filling | Sham comparator | 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 Receives: Device: GIC |
| Biodentine filling | Experimental | 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. Receives: Device: Biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
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
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start3 Jan 2015
- Primary completion30 Jun 2015
- Study completion28 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rola Abdelraheem Alhabashneh, Jordan University of Science and Technology
- Investigators
- Rola Al Habashneh, ABP, Study director, JUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418246
- Sponsor's protocol ID
- JordanUST5
- Status last verified
- Jan 2018
- First submitted
- 6 Jan 2018
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Health Around Cervical Carious Lesions Restored With Calcium Silicate Based Cement (Biodentine) Compared With Glass-ionomer Cement: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03418246
- Acronym / sponsor ID
- JordanUST5
- Conditions
- Gingivitis
- Keywords
- gingiva, plaque, pocket depth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 3 Jan 2015 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 28 Dec 2015 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| GIC filling | Sham comparator | Device: GICIntervention/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 |
| Biodentine filling | Experimental | Device: BiodentineIntervention/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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- good general health;
- good oral hygiene; and
- age range 18-60 years old.
- current smokers;
- pregnant females;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GICtooth colored filling | Device | GIC filling |
| BiodentineAlso: Calcium CilicateWhite filling -Biodentine | Device | Biodentine filling |
Primary outcome
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 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
1 secondary outcome
Changes in Pocket Depth around Cervical Carious Lesions Restored with Calcium
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rola Al Habashneh, ABP study director
JUST
Questions about this trial
What is this clinical trial studying?
A study testing GIC and Biodentine in people with Gingivitis, run by Jordan University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Gingival index around Cervical Carious Lesions Restored with Calcium Silicate Based Cement (Biodentine™) Compared with Glass-Ionomer Cement; (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.