Radiographic Assessment of Calcific Bridge Formation by Light Activated Calcium Silicate Versus Calcium Hydroxide for Deep Caries

NCT ID: NCT03233893

Last Updated: 2018-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2018-12-01

Brief Summary

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sixty participants will be divided in to two groups (n=30) of patient treated by partial caries removal according to the capping material (A),where (A1)represents calcium silicate group,(A2)represent calcium hydroxide group.Apply light activated calcium silicate for group (A1) in deep occlusal caries and taking the base line image after restoring the cavity with composite restoration and apply light activated calcium hydroxide for(A2)group in deep occlusal caries and taking the base line image after restoring with composite restoration.Take follow up image after one year to measure the calcific bridge formation for both groups.

Detailed Description

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Management of deep carious lesion may constitute a real challenge for the operator.The basic idea for treating deep caries is to enhance calcific reparative capacity.Calcium hydroxide has been the gold standard as a capping material but there are some drawbacks like solubility,gaps formation and mechanical instability so a need for a capping material such as calcium silicate has shown several advantages.

Sixty participants will be divided in to two groups (n=30) of patient treated by partial caries removal.The first group(A1) will be treated by light activated calcium silicate and the second group(A2) will be treated by light activated calcium hydroxide after partial caries removal of deep occlusal caries then restore by composite restoration.Paralleling technique using film holders and custom made bite blocks will be used to standardize the serial radiographs and to prevent the distortion of the radiographic image.An increase in dentin thickness will be measured through sequential imaging by soft ware named Digora (Digora Optime,Soredex,Helsinki,Finland) will be used for measurements by digitalizing the scanned image.All images will be studied carefully for an increase in dentin thickness keeping the reference point constant from the furcation area.

Conditions

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Deep Carious Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The patient and the outcome assessor will be blinded in this study

Study Groups

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light activated calcium silicate

Apply light activated calcium silicate in deep occlusal caries lesions and taking the base line image for the first group after restoring the cavity with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.

Group Type EXPERIMENTAL

light activated calcium silicate

Intervention Type OTHER

for the first group light activated calcium silicate can be easily placed by a 20 second light cure and ability to be syringed directly on to the cavity preparation and restore the cavity by composite restoration.

for the second group using light activated calcium hydroxide is placed by placing a disposable tip securely on to the syringe then light cure for 20 seconds depending on the light cure unit and restore the cavity with composite restoration.

light activated calcium hydroxide

Apply the light activated calcium hydroxide in deep occlusal carious lesions and taking the base line image for the second group after restoring with composite restoration and taking the follow up x-ray image after one year to measure the calcific bridge formation.

Group Type ACTIVE_COMPARATOR

light activated calcium silicate

Intervention Type OTHER

for the first group light activated calcium silicate can be easily placed by a 20 second light cure and ability to be syringed directly on to the cavity preparation and restore the cavity by composite restoration.

for the second group using light activated calcium hydroxide is placed by placing a disposable tip securely on to the syringe then light cure for 20 seconds depending on the light cure unit and restore the cavity with composite restoration.

Interventions

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light activated calcium silicate

for the first group light activated calcium silicate can be easily placed by a 20 second light cure and ability to be syringed directly on to the cavity preparation and restore the cavity by composite restoration.

for the second group using light activated calcium hydroxide is placed by placing a disposable tip securely on to the syringe then light cure for 20 seconds depending on the light cure unit and restore the cavity with composite restoration.

Intervention Type OTHER

Other Intervention Names

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light activated calcium hydroxide

Eligibility Criteria

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Inclusion Criteria

* Normal adults will be recruited in this study ,all the volunteers participated in this experiment will be healthy looking free medical history.
* Patients have simple deep carious lesions in his /her mouth with no pain or history of sensitivity to cold which disappear immediately after removal of the stimulus.

Exclusion Criteria

* Medically compromised patients and teeth with history of spontaneous pain or tenderness to percussion were excluded from the study.
* Pregnant females will be excluded from the study.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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basma gamal hassan

Resident of conservative department ,faculty of oral and dental medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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basma gamal hassan, master

Role: CONTACT

01011137104

basma gamal hassan, master

Role: CONTACT

01011137104

References

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Grewal N, Salhan R, Kaur N, Patel HB. Comparative evaluation of calcium silicate-based dentin substitute (Biodentine(R)) and calcium hydroxide (pulpdent) in the formation of reactive dentin bridge in regenerative pulpotomy of vital primary teeth: Triple blind, randomized clinical trial. Contemp Clin Dent. 2016 Oct-Dec;7(4):457-463. doi: 10.4103/0976-237X.194116.

Reference Type RESULT
PMID: 27994411 (View on PubMed)

Related Links

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http://www.contempclindent.org

comparative evaluation of calcium silicate -based dentin substitute (Biodentine) and calcium hydroxide (pulpdent) in the formation of reactive dentin bridge in regenerative pulpotomy of vital primary teeth

Other Identifiers

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CEBC-CU-2017-07-21

Identifier Type: -

Identifier Source: org_study_id

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