Deep CariesNCT02918903
Evaluation of Pulp Symptoms After Minimal Caries Removal in Treatment of Deep Caries
A study testing Minimal caries removal and Complete caries removal in people with Deep Caries, run by Cairo University at 1 site in Egypt.
Trial summary
The objective of this study is to assess and compare the possible post-operative pulpal symptoms (Spontaneous pain, pain on percussion, swelling, sinus or fistula), incidence of pulp exposure, child acceptance, chair time and radiographic success between two techniques for managing dental caries: minimal caries… Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries
- What is being tested?
- Minimal caries removal and Complete caries removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2018to 15 Jul 2020
- Phase
- Interventional
- 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
- Primary molar with deep dentin caries involving occlusal \&/or occluso-proximal surfaces.
- Absence of clinical signs and symptoms of irreversible pulpitis such as spontaneous pain. Only presence of pain provoked with stimulation, such as complaints of food impaction when eating is allowed.
- Absence of clinical swelling or pus exudates/fistula of soft or periodontal tissues.
- Absence of abnormal tooth mobility.
- Absence of pain on percussion.
- Restorable tooth.
Show all 13Show fewer
- Radiographic inclusion criteria:
- Extension of dental caries one-third or more of the entire dentin thickness.
- No super- imposition of dental caries on the dental pulp.
- No widened periodontal ligament (PDL) space.
- No radiolucency in the peri-apical or furcation areas.
- No pathologic internal or external root resorption.
- No pulp canal calcification or obliteration.
Who cannot join
- Patients experience any signs or symptoms of pulpal or peri-apical pathology.
- Patients with systemic diseases requiring special dental consideration.
- Unmotivated, uncooperative patients.
- Patients unable to attend follow-up visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pulpal Symptoms Following Minimal Caries Removal Technique in Comparison to Complete Caries Removal in Molars With Deep Caries
The objective of this study is to assess and compare the possible post-operative pulpal symptoms (Spontaneous pain, pain on percussion, swelling, sinus or fistula), incidence of pulp exposure, child acceptance, chair time and radiographic success between two techniques for managing dental caries: minimal caries removal and complete caries removal in primary molars.
Read the detailed description
Minimal Caries Removal (MCR) technique was described in 2015 by Chompu-inwai et al., as a treatment option for primary molars with deep carious lesions or reversible pulpitis where only soft demineralized dentin around the lateral walls of the carious lesion is removed. The aim of this study is to assess the success of such a technique in managing primary molars with asymptomatic deep caries in terms of; post-operative pulpal symptoms(spontaneous pain, pain on percussion, fistula or sinus), incidence of pulp exposure, child acceptance, chair time and radiographic success.
- Conditions
- Deep Caries
- Being tested
- Minimal caries removal, Complete caries removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal caries removalProcedure or surgery
the experimental group will be treated by minimal caries removal where only caries at lateral walls of cavity will be removed then stainless steel crown will be placed as final restoration.
Complete caries removalProcedure or surgery
the control group will be treated by complete caries removal where all caries along lateral and pulpal walls of cavity will be removed, a base of resin modified glass ionomer will be placed then stainless steel crown will be placed as final restoration.
| Study group | Role | What they receive |
|---|---|---|
| Minimal caries removal | Experimental | the patients in this group will be treated by minimal caries removal technique, where only caries at lateral walls of cavity is removed, stainless steel crown preparation is performed and then stainless steel crown is placed as final restoration. Receives: Procedure: Minimal caries removal |
| Complete caries removal | Active comparator | patients in this group will be treated by complete caries removal technique, where all caries will be removed, a base of resin modified glass ionomer is placed and then stainless steel crown is placed as final restoration. Receives: Procedure: Complete caries removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain assessed by direct questioning as binary outcome
Assessed by direct questioning pain history
Measured: 9 months
Secondary outcomes (2)
incidence of pulp exposure
The outcome will be measured during the treatment visit which is estimated to be 30 minutes
Measured: Within 30 minutes
radio-graphic success
No external or internal root resorption, no periapical or furcation radiolucencies, no widening of periodontal membrane space
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start15 Dec 2018
- Primary completion15 Mar 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Mamdouh Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918903
- Sponsor's protocol ID
- CEBD-CU-2016-09-206
- Status last verified
- Jun 2021
- First submitted
- 26 Sep 2016
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pulpal Symptoms Following Minimal Caries Removal Technique in Comparison to Complete Caries Removal in Molars With Deep Caries
- ClinicalTrials.gov ID
- NCT02918903
- Acronym / sponsor ID
- CEBD-CU-2016-09-206
- Conditions
- Deep Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 29 Sep 2016 (estimated)
- 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 assess and compare the possible post-operative pulpal symptoms (Spontaneous pain, pain on percussion, swelling, sinus or fistula), incidence of pulp exposure, child acceptance, chair time and radiographic success between two techniques for managing dental caries: minimal caries removal and complete caries removal in primary molars.
Detailed description
Minimal Caries Removal (MCR) technique was described in 2015 by Chompu-inwai et al., as a treatment option for primary molars with deep carious lesions or reversible pulpitis where only soft demineralized dentin around the lateral walls of the carious lesion is removed. The aim of this study is to assess the success of such a technique in managing primary molars with asymptomatic deep caries in terms of; post-operative pulpal symptoms(spontaneous pain, pain on percussion, fistula or sinus), incidence of pulp exposure, child acceptance, chair time 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 |
|---|---|---|
| Minimal caries removal | Experimental | Procedure: Minimal caries removalthe patients in this group will be treated by minimal caries removal technique, where only caries at lateral walls of cavity is removed, stainless steel crown preparation is performed and then stainless steel crown is placed as final restoration. |
| Complete caries removal | Active comparator | Procedure: Complete caries removalpatients in this group will be treated by complete caries removal technique, where all caries will be removed, a base of resin modified glass ionomer is placed and then stainless steel crown is placed as final restoration. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Primary molar with deep dentin caries involving occlusal \&/or occluso-proximal surfaces.
- Absence of clinical signs and symptoms of irreversible pulpitis such as spontaneous pain. Only presence of pain provoked with stimulation, such as complaints of food impaction when eating is allowed.
- Absence of clinical swelling or pus exudates/fistula of soft or periodontal tissues.
- Absence of abnormal tooth mobility.
- Absence of pain on percussion.
Key exclusion criteria (4 listed)
- Patients experience any signs or symptoms of pulpal or peri-apical pathology.
- Patients with systemic diseases requiring special dental consideration.
- Unmotivated, uncooperative patients.
- Patients unable to attend follow-up visits.
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 |
|---|---|---|
| Minimal caries removalthe experimental group will be treated by minimal caries removal where only caries at lateral walls of cavity will be removed then stainless steel crown will be placed as final restoration. | Procedure or surgery | Minimal caries removal |
| Complete caries removalthe control group will be treated by complete caries removal where all caries along lateral and pulpal walls of cavity will be removed, a base of resin modified glass ionomer will be placed then stainless steel crown will be placed as final restoration. | Procedure or surgery | Complete caries removal |
Primary outcome
Post operative pain assessed by direct questioning as binary outcome
Time frame: 9 months
Assessed by direct questioning pain history
2 secondary outcomes
incidence of pulp exposure
Time frame: Within 30 minutes
radio-graphic success
Time frame: 9 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 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Deep Caries
RecruitingPhase 2
Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries
Deep Caries
Recruiting
"The Relationship Between Pulpal Inflammatory Marker Levels in Moderate and Severe Pulpitis and Outcome of Full Pulpotomy in Mandibular Molars With Extremely Deep Caries: A Prospective Cohort Study."
Moderate Severe Pulpitis, Extremely Deep Caries
Recruiting
Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite
Symptomatic Irreversible Pulpitis (SIP), Extremely Deep Caries
Active, not recruiting
Outcome of Selective Caries Removal Performed by Undergraduate Students
Deep Caries Lesion of Pemanent Teeth
Enrolling by invitation
Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions.
Dental Caries, Dental Cavities
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal caries removal and Complete caries removal in people with Deep 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 13 inclusion and 4 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 Jun 2021. 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.
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?
Post operative pain assessed by direct questioning as binary outcome (time frame: 9 months). 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 Jun 2021.