Deep Carious LesionPhase 4NCT03791255
Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars
A Phase 4 study testing Calcium silicate liner and Calcium hydroxide liner in people with Deep Carious Lesion and Indirect Pulp Treatment, run by Cairo University.
Trial summary
The objective of this study is to explore if light cured resin modified Calcium silicate could result in better clinical and radiographic success if compared to light cured Calcium hydroxide when used in indirect pulp capping treatment in primary molars. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Carious Lesion, Indirect Pulp Treatment
- What is being tested?
- Calcium silicate liner and Calcium hydroxide liner
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Feb 2021
- Phase
- Phase 4
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Medically free children.
- Age range from 4-7 years.
- Presence of lower second primary molars with deep carious occlusal lesion.
- No history of spontaneous pain (reversible pulpitis).
- Clinically: Absence of swelling, sinus, fistula, pain on percussion and tooth mobility.
- Radiographically: Absence of radiolucent lesions at furcation or periapical region and absence of internal or external root resorption.
Who cannot join
- Uncooperative children.
- Any unmet previous criterion.
About this study
Official title: Clinical and Radiographic Evaluation of Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars
The objective of this study is to explore if light cured resin modified Calcium silicate could result in better clinical and radiographic success if compared to light cured Calcium hydroxide when used in indirect pulp capping treatment in primary molars.
Read the detailed description
To evaluate clinical and radiographic success of resin modified calcium silicate in comparison to light cured calcium hydroxide as indirect pulp capping materials in primary molars.
P: Children aged (4-7 years) with deep carious lesions in lower primary second molars indicated for indirect pulp treatment.
I: Indirect pulp treatment using light cured resin modified Calcium Silicate (TheraCal).
C: Indirect pulp treatment using light cured Calcium Hydroxide. O: clinical and radiographic success.
- Conditions
- Deep Carious Lesion, Indirect Pulp Treatment
- Being tested
- Calcium silicate liner, Calcium hydroxide liner
- Keywords
- resin modified calcium silicate, indirect pulp treatment, primary molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium silicate linerDrug
new light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping
Calcium hydroxide linerDrug
Calcium hydroxide is the gold standard for pulp capping, allows for the formation of a reparative dentin bridge
| Study group | Role | What they receive |
|---|---|---|
| Resin Modified Calcium Silicate | Experimental | light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping Receives: Drug: Calcium silicate liner |
| Light Cured Calcium Hydroxide | Active comparator | gold standard for pulp capping, It allows for the formation of a reparative dentine bridge through cellular differentiation, extracellular matrix secretion and subsequent mineralization. Receives: Drug: Calcium hydroxide liner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Pain questionnaire (binary yes/no)
Measured: 1 month
Postoperative pain
Pain questionnaire (binary yes/no)
Measured: 3 months
Postoperative pain
Pain questionnaire (binary yes/no)
Measured: 6 months
Postoperative pain
Pain questionnaire (binary yes/no)
Measured: 12 months
Secondary outcomes (28)
Swelling
Visual examination by the operator (binary yes/no)
Measured: 1 month
Swelling
Visual examination by the operator (binary yes/no)
Measured: 3 months
Swelling
Visual examination by the operator (binary yes/no)
Measured: 6 months
Swelling
Visual examination by the operator (binary yes/no)
Measured: 12 months
Sinus or fistula
Visual examination by the operator (binary yes/no)
Measured: 1 month
Sinus or fistula
Visual examination by the operator (binary yes/no)
Measured: 3 months
Sinus or fistula
Visual examination by the operator (binary yes/no)
Measured: 6 months
Sinus or fistula
Visual examination by the operator (binary yes/no)
Measured: 12 months
Tooth mobility
back of the mirror to check mobility (binary yes/no)
Measured: 1 month
Tooth mobility
back of the mirror to check mobility (binary yes/no)
Measured: 3 months
Tooth mobility
back of the mirror to check mobility (binary yes/no)
Measured: 6 months
Tooth mobility
back of the mirror to check mobility (binary yes/no)
Measured: 12 months
pain on percussion
back of the mirror to check pain on percussion (binary yes/no)
Measured: 1 month
pain on percussion
back of the mirror to check pain on percussion (binary yes/no)
Measured: 3 months
pain on percussion
back of the mirror to check pain on percussion (binary yes/no)
Measured: 6 months
pain on percussion
back of the mirror to check pain on percussion (binary yes/no)
Measured: 12 months
Occurrence of radiolucent lesions at furcation or periapical region
(binary yes/no)
Measured: 1 months
Occurrence of radiolucent lesions at furcation or periapical region
(binary yes/no)
Measured: 3 months
Occurrence of radiolucent lesions at furcation or periapical region
(binary yes/no)
Measured: 6 months
Occurrence of radiolucent lesions at furcation or periapical region
(binary yes/no)
Measured: 12 months
widening in the periodontal membrane space
(binary yes/no)
Measured: 1 month
widening in the periodontal membrane space
(binary yes/no)
Measured: 3 months
widening in the periodontal membrane space
(binary yes/no)
Measured: 6 months
widening in the periodontal membrane space
(binary yes/no)
Measured: 12 months
presence of internal or external root resorption
(binary yes/no)
Measured: 1 month
presence of internal or external root resorption
(binary yes/no)
Measured: 3 months
presence of internal or external root resorption
(binary yes/no)
Measured: 6 months
presence of internal or external root resorption
(binary yes/no)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study startFeb 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Carious LesionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Ashraf Elbanna, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791255
- Sponsor's protocol ID
- Indirect pulp primary molars
- Status last verified
- Jan 2019
- First submitted
- 27 Dec 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Light Cured Resin Modified Calcium Silicate Versus Light Cured Calcium Hydroxide in Indirect Pulp Treatment of Primary Molars
- ClinicalTrials.gov ID
- NCT03791255
- Acronym / sponsor ID
- Indirect pulp primary molars
- Conditions
- Deep Carious Lesion, Indirect Pulp Treatment
- Keywords
- resin modified calcium silicate, indirect pulp treatment, primary molars
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 2 Jan 2019 (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.
The objective of this study is to explore if light cured resin modified Calcium silicate could result in better clinical and radiographic success if compared to light cured Calcium hydroxide when used in indirect pulp capping treatment in primary molars.
Detailed description
To evaluate clinical and radiographic success of resin modified calcium silicate in comparison to light cured calcium hydroxide as indirect pulp capping materials in primary molars.
P: Children aged (4-7 years) with deep carious lesions in lower primary second molars indicated for indirect pulp treatment.
I: Indirect pulp treatment using light cured resin modified Calcium Silicate (TheraCal).
C: Indirect pulp treatment using light cured Calcium Hydroxide. O: clinical and radiographic success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin Modified Calcium Silicate | Experimental | Drug: Calcium silicate linerlight-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping |
| Light Cured Calcium Hydroxide | Active comparator | Drug: Calcium hydroxide linergold standard for pulp capping, It allows for the formation of a reparative dentine bridge through cellular differentiation, extracellular matrix secretion and subsequent mineralization. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Medically free children.
- Age range from 4-7 years.
- Presence of lower second primary molars with deep carious occlusal lesion.
- No history of spontaneous pain (reversible pulpitis).
- Clinically: Absence of swelling, sinus, fistula, pain on percussion and tooth mobility.
Key exclusion criteria (2 listed)
- Uncooperative children.
- Any unmet previous criterion.
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 |
|---|---|---|
| Calcium silicate linernew light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping | Drug | Resin Modified Calcium Silicate |
| Calcium hydroxide linerCalcium hydroxide is the gold standard for pulp capping, allows for the formation of a reparative dentin bridge | Drug | Light Cured Calcium Hydroxide |
Primary outcome
Postoperative pain
Time frame: 1 month
Pain questionnaire (binary yes/no)
Postoperative pain
Time frame: 3 months
Pain questionnaire (binary yes/no)
Postoperative pain
Time frame: 6 months
Pain questionnaire (binary yes/no)
Postoperative pain
Time frame: 12 months
Pain questionnaire (binary yes/no)
28 secondary outcomes
Swelling
Time frame: 1 month
Swelling
Time frame: 3 months
Swelling
Time frame: 6 months
Swelling
Time frame: 12 months
Sinus or fistula
Time frame: 1 month
Sinus or fistula
Time frame: 3 months
Sinus or fistula
Time frame: 6 months
Sinus or fistula
Time frame: 12 months
Tooth mobility
Time frame: 1 month
Tooth mobility
Time frame: 3 months
Tooth mobility
Time frame: 6 months
Tooth mobility
Time frame: 12 months
pain on percussion
Time frame: 1 month
pain on percussion
Time frame: 3 months
pain on percussion
Time frame: 6 months
pain on percussion
Time frame: 12 months
Occurrence of radiolucent lesions at furcation or periapical region
Time frame: 1 months
Occurrence of radiolucent lesions at furcation or periapical region
Time frame: 3 months
Occurrence of radiolucent lesions at furcation or periapical region
Time frame: 6 months
Occurrence of radiolucent lesions at furcation or periapical region
Time frame: 12 months
widening in the periodontal membrane space
Time frame: 1 month
widening in the periodontal membrane space
Time frame: 3 months
widening in the periodontal membrane space
Time frame: 6 months
widening in the periodontal membrane space
Time frame: 12 months
presence of internal or external root resorption
Time frame: 1 month
presence of internal or external root resorption
Time frame: 3 months
presence of internal or external root resorption
Time frame: 6 months
presence of internal or external root resorption
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcium silicate liner and Calcium hydroxide liner in people with Deep Carious Lesion and Indirect Pulp Treatment, run by Cairo University.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Jan 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Postoperative pain (time frame: 1 month). The study lists 4 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 15 Jan 2019.