Dental CariesPhase 4RCTNCT03770871
Indirect Pulp Treatment in Primary Molars
A Phase 4 study testing Indirect pulp treatment using Dycal (TM) and Indirect pulp treatment using Vitrebond (TM ) in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
This study was conducted to evaluate the clinical and the radiographic success of Dycal and Vitrebond as indirect pulp treatment materials in primary molars. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Indirect pulp treatment using Dycal (TM) and Indirect pulp treatment using Vitrebond (TM )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2016to Jul 2018
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- In compliance with AAPD, 2017 guidelines for pulp therapy "IPT is indicated in a primary tooth with no pulpitis or with reversible pulpitis when the deepest carious dentin is not removed to avoid a pulp exposure. The pulp is judged by clinical and radiographic criteria to be vital and able to heal from the carious insult"
- In addition to:
- I-Subjects:
- Medically free children, their parent(s) accepts to sign the informed consent.
- Age range from 4-8 years.
- II-Molars:
Show all 9Show fewer
- Presence of at least 1 primary molar with deep carious lesion extending to more than one half of the dentin on radiographic examination (to make the trial regardless of number of carious molars).
- Clinically: Normal mobility and normal appearance of gingiva (vital teeth).
- Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT).
Who cannot join
- I-Subjects:
- Uncooperative children.
- Parents unable to attend follow up visits (even after explaining the importance of recall visits).
- II-Molars:
- History of spontaneous pain (to exclude reversible pulpitis).
- Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth).
- Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Resin Modified Glass Ionomer Liner (Vitrebond™) Versus Calcium Hydroxide as Indirect Pulp Treatment Material Used in Deep Carious Lesions in Primary Molars: A Randomized Clinical Trial
This study was conducted to evaluate the clinical and the radiographic success of Dycal and Vitrebond as indirect pulp treatment materials in primary molars.
Read the detailed description
Evaluation of calcium hydroxide and resin modified glass ionomer liner clinically and radiographically as indirect pulp treatment materials in deep caries in primary molars.
- Conditions
- Dental Caries
- Being tested
- Indirect pulp treatment using Dycal (TM), Indirect pulp treatment using Vitrebond (TM )
- Keywords
- indirect pulp, primary, calcium hydroxide, resin modified glass ionomer, Children
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect pulp treatment using Dycal (TM)Drug
Also called Indirect pulp capping
Partial caries removal and protection of the dental pulp with biocompatible material
Indirect pulp treatment using Vitrebond (TM )Drug
Also called Indirect pulp capping
Partial caries removal and protection of the dental pulp with biocompatible material
| Study group | Role | What they receive |
|---|---|---|
| IPT using Dycal (TM ) | Active comparator | Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal Receives: Drug: Indirect pulp treatment using Dycal (TM); Drug: Indirect pulp treatment using Vitrebond (TM ) |
| IPT using Vitrebond (TM ) | Experimental | Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal Receives: Drug: Indirect pulp treatment using Dycal (TM); Drug: Indirect pulp treatment using Vitrebond (TM ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases reporting postoperative pain
Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure
Measured: 12 months
Number of cases reporting swelling
Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure
Measured: 12 months
Number of cases reporting sinus
Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure
Measured: 12 months
Number of cases reporting fistula
Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure
Measured: 12 months
Number of cases reporting tooth mobility
Presence of abnormal tooth mobility following dental treatment through tactile examination using two hand mirrors as a sign of clinical failure
Measured: 12 months
Secondary outcomes (5)
Number of cases reporting external root resorption
Occurrence of pathological external root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
Measured: 12 months
Number of cases reporting internal root resorption
Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
Measured: 12 months
Number of cases reporting furcation involvement
Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
Measured: 12 months
Number of cases reporting widening of periodontal membrane space
Occurrence of widening of periodontal membrane space following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
Measured: 12 months
Number of cases reporting periapical radiolucency
Occurrence of periapical radiolucency following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
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 posted10 Dec 2018
- Study startAug 2016
- Primary completionAug 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Model description
- Parallel group with 1:1 allocation ratio
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Farouk Rashed, Cairo University
- Investigators
- Shereen E Taha, Professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770871
- Sponsor's protocol ID
- CEBD-CU-2014-11-3
- Acronym
- RCT
- Status last verified
- Aug 2019
- First submitted
- 18 Aug 2018
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: final results
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Resin Modified Glass Ionomer Liner (Vitrebond™) Versus Calcium Hydroxide as Indirect Pulp Treatment Material Used in Deep Carious Lesions in Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03770871
- Acronym / sponsor ID
- RCT / CEBD-CU-2014-11-3
- Conditions
- Dental Caries
- Keywords
- indirect pulp, primary, calcium hydroxide, resin modified glass ionomer, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 10 Dec 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 was conducted to evaluate the clinical and the radiographic success of Dycal and Vitrebond as indirect pulp treatment materials in primary molars.
Detailed description
Evaluation of calcium hydroxide and resin modified glass ionomer liner clinically and radiographically as indirect pulp treatment materials in deep caries in primary molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group with 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| IPT using Dycal (TM ) | Active comparator | Drug: Indirect pulp treatment using Dycal (TM), Drug: Indirect pulp treatment using Vitrebond (TM )Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal |
| IPT using Vitrebond (TM ) | Experimental | Drug: Indirect pulp treatment using Dycal (TM), Drug: Indirect pulp treatment using Vitrebond (TM )Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- In compliance with AAPD, 2017 guidelines for pulp therapy "IPT is indicated in a primary tooth with no pulpitis or with reversible pulpitis when the deepest carious dentin is not removed to avoid a pulp exposure. The pulp is judged by clinical and radiographic criteria to be vital and able to heal from the carious insult"
- Medically free children, their parent(s) accepts to sign the informed consent.
- Age range from 4-8 years.
- Presence of at least 1 primary molar with deep carious lesion extending to more than one half of the dentin on radiographic examination (to make the trial regardless of number of carious molars).
- Clinically: Normal mobility and normal appearance of gingiva (vital teeth).
Key exclusion criteria (7 listed)
- Uncooperative children.
- Parents unable to attend follow up visits (even after explaining the importance of recall visits).
- History of spontaneous pain (to exclude reversible pulpitis).
- Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth).
- Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).
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 |
|---|---|---|
| Indirect pulp treatment using Dycal (TM)Also: Indirect pulp cappingPartial caries removal and protection of the dental pulp with biocompatible material | Drug | IPT using Dycal (TM ), IPT using Vitrebond (TM ) |
| Indirect pulp treatment using Vitrebond (TM )Also: Indirect pulp cappingPartial caries removal and protection of the dental pulp with biocompatible material | Drug | IPT using Dycal (TM ), IPT using Vitrebond (TM ) |
Primary outcome
Number of cases reporting postoperative pain
Time frame: 12 months
Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure
Number of cases reporting swelling
Time frame: 12 months
Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure
Number of cases reporting sinus
Time frame: 12 months
Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure
Number of cases reporting fistula
Time frame: 12 months
Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure
Number of cases reporting tooth mobility
Time frame: 12 months
Presence of abnormal tooth mobility following dental treatment through tactile examination using two hand mirrors as a sign of clinical failure
5 secondary outcomes
Number of cases reporting external root resorption
Time frame: 12 months
Number of cases reporting internal root resorption
Time frame: 12 months
Number of cases reporting furcation involvement
Time frame: 12 months
Number of cases reporting widening of periodontal membrane space
Time frame: 12 months
Number of cases reporting periapical radiolucency
Time frame: 12 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 30 Aug 2019.
- Individual participant dataSharing planned: No. final results
Related trials for Dental Caries
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
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.
Shereen E Taha, Professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indirect pulp treatment using Dycal (TM) and Indirect pulp treatment using Vitrebond (TM ) in people with Dental Caries, run by Cairo University at 1 site in Egypt.
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 9 inclusion and 7 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 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
Number of cases reporting postoperative pain (time frame: 12 months). The study lists 5 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 30 Aug 2019.