Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 93 of 1201 for:    tooth decay

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

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: NCT03233893
Recruitment Status : Unknown
Verified July 2017 by basma gamal hassan, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : July 31, 2017
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
basma gamal hassan, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Deep Carious Lesions Other: light activated calcium silicate Not Applicable

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The patient and the outcome assessor will be blinded in this study
Primary Purpose: Treatment
Official Title: Radiographic Assessment of Calcific Bridge Formation by Light Activated Calcium Silicate Versus Light Activated Calcium Hydroxide in Management of Simple Deeply Seated Carious Lesions With Partial Caries Removal
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Tooth Decay

Arm Intervention/treatment
Experimental: 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.
Other: 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.

Other Name: light activated calcium hydroxide

Active Comparator: 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.
Other: 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.

Other Name: light activated calcium hydroxide




Primary Outcome Measures :
  1. calcific bridge formation will be measured by digora software [ Time Frame: 1 year ]
    in millimeters



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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03233893


Contacts
Layout table for location contacts
Contact: basma gamal hassan, master 01011137104 basmadental1@gmail.com
Contact: basma gamal hassan, master 01011137104 basmadental1@gmail.om

Sponsors and Collaborators
Cairo University

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: basma gamal hassan, Resident of conservative department ,faculty of oral and dental medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03233893     History of Changes
Other Study ID Numbers: CEBC-CU-2017-07-21
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2017
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

Keywords provided by basma gamal hassan, Cairo University:
based dentin substitute
dentin bridge
tertiary dentin
indirect pulp treatment

Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Calcium
Calcium, Dietary
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents