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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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

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

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 groups in NCT03791255
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.

Feb 2019Feb 2021

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)

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