Deep CariesNCT03631277
Indirect Pulp Treatment of Young Permanent Molars Using Photo-Activated Oral Disinfection Versus Calcium Hydroxide
A study testing photo-activated oral disinfection and Calcium Hydroxide in people with Deep Caries, run by Cairo University.
Trial summary
This study aimed to assess the clinical and radiographic success for photo-activated oral disinfection (PAD) and calcium hydroxide in indirect pulp treatment (IPT) of young permanent molars. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Deep Caries
- What is being tested?
- photo-activated oral disinfection and Calcium Hydroxide
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Apr 2017
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Restorable lower first permanent molars with deep carious lesions
- Absence of clinical signs and symptoms of irreversible pulpitis, fistula, swelling in periodontal tissues or abnormal tooth mobility
- Absence of adverse radiographic findings
- Compliant patient/parent and (e) Absence of any systemic disease.
Who cannot join
- Previously restored teeth .
About this study
Official title: Clinical and Radiographic Evaluation of Indirect Pulp Treatment of Young Permanent Molars Using Photo-Activated Oral Disinfection Versus Calcium Hydroxide: A Randomized Clinical Trial
This study aimed to assess the clinical and radiographic success for photo-activated oral disinfection (PAD) and calcium hydroxide in indirect pulp treatment (IPT) of young permanent molars.
Read the detailed description
Indirect pulp treatment is a procedure in which pulp exposure is prevented by preserving the carious dentin bordering the pulp and sealing the pulp with a biocompatible material. . Calcium hydroxide is the gold standard for pulp capping, it permits reparative dentin bridge formation, maintains pulp vitality, protects the pulp against harmful stimuli and has antimicrobial effect. However, several disadvantages were reported with its use over time including poor seal, lack of chemical and mechanical adhesion, poor strength, long-term solubility, enhanced degradation after acid etching and tunnel defects in the dentin bridge . The operative tradition is to remove softened dentin to eliminate infected tissue; however, it is impossible to eradicate all the micro-organisms because few will persist although all soft dentin was excavated.
Evidence suggest that for arresting caries lesions, it is not crucial to completely remove the infected dentin and that selective caries removal and composite restoration can yield better clinical results . For more conservative and effective treatment, disinfection instead of complete caries removal has been encouraged. . PAD is an advanced technology utilizing two non-toxic components, a photo-activating liquid and a LED light source that selectively target and abolish cariogenic bacteria and periodontal pathogens . The usage of PAD in caries management can eradicate residual bacteria in soft dentin, reassures rapid healing and improve the prognosis of treatment .
- Conditions
- Deep Caries
- Being tested
- photo-activated oral disinfection, Calcium Hydroxide
- Keywords
- Indirect pulp treatment, Photo-activated oral disinfection, Calcium Hydroxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photo-activated oral disinfectionDevice
Also called PAD
Application of PAD solution using disposable tip with agitation of the solution for 60 seconds using a brush; Placement of the light disposable tip in center of lesion and holding it just above the surface; Activation of the red light for 60 seconds; (h)Sealing the cavity with glass ionomer and then filling with composite resin as a final restoration
Calcium HydroxideDrug
Also called Ca(OH)2
calcium hydroxide( Dycal ® Dentsply Caulk )was applied using calcium hydroxide applicator followed by glass ionomer and then composite resin as a final restoration
| Study group | Role | What they receive |
|---|---|---|
| photo-activated oral disinfection | Experimental | photo-activated oral disinfection is an advanced technology utilizing two non-toxic components, a photo-activating liquid and a LED light source that selectively target and abolish cariogenic bacteria and periodontal pathogens Receives: Device: photo-activated oral disinfection |
| calcium hydroxide | Active comparator | Calcium hydroxide is the gold standard for pulp capping, it permits reparative dentin bridge formation, maintains pulp vitality, protects the pulp against harmful stimuli and has antimicrobial effect Receives: Drug: Calcium Hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain: verbal rating scale
categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome
Measured: 2 months
postoperative pain: verbal rating scale
categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome
Measured: 6 months
postoperative pain: verbal rating scale
categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome
Measured: 9 months
postoperative pain: verbal rating scale
categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome.
Measured: 12 months
Secondary outcomes (5)
Presence or absence of pain on percussion
Binary outcome (Present or absent). Assessed by tapping the tooth with the back of the mirror
Measured: 2,6,9 and 12 months
Swelling
Binary outcome (Present or absent). Assessed by visual examination by the examiner
Measured: 2,6,9 and 12 months
Sinus or fistula
Binary outcome (Present or absent). Assessed by visual examination by the examiner
Measured: 2,6,9 and 12 months
Adverse radiographic findings
Binary outcome (Present or absent). Assessed by Digora software
Measured: 2,6,9 and 12 months
Thickness of newly formed dentin
using the Digora software. Unit of measurements were mm
Measured: 2,6,9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study startJan 2015
- Primary completionJan 2017
- Study completionApr 2017
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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa aly fouad elchaghaby, Cairo University
- Investigators
- Ahmed M Abd Alsamad, PHD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631277
- Sponsor's protocol ID
- pulp capping
- Status last verified
- Aug 2018
- First submitted
- 12 Aug 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Indirect Pulp Treatment of Young Permanent Molars Using Photo-Activated Oral Disinfection Versus Calcium Hydroxide: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03631277
- Acronym / sponsor ID
- pulp capping
- Conditions
- Deep Caries
- Keywords
- Indirect pulp treatment, Photo-activated oral disinfection, Calcium Hydroxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 15 Aug 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 aimed to assess the clinical and radiographic success for photo-activated oral disinfection (PAD) and calcium hydroxide in indirect pulp treatment (IPT) of young permanent molars.
Detailed description
Indirect pulp treatment is a procedure in which pulp exposure is prevented by preserving the carious dentin bordering the pulp and sealing the pulp with a biocompatible material. . Calcium hydroxide is the gold standard for pulp capping, it permits reparative dentin bridge formation, maintains pulp vitality, protects the pulp against harmful stimuli and has antimicrobial effect. However, several disadvantages were reported with its use over time including poor seal, lack of chemical and mechanical adhesion, poor strength, long-term solubility, enhanced degradation after acid etching and tunnel defects in the dentin bridge . The operative tradition is to remove softened dentin to eliminate infected tissue; however, it is impossible to eradicate all the micro-organisms because few will persist although all soft dentin was excavated.
Evidence suggest that for arresting caries lesions, it is not crucial to completely remove the infected dentin and that selective caries removal and composite restoration can yield better clinical results . For more conservative and effective treatment, disinfection instead of complete caries removal has been encouraged. . PAD is an advanced technology utilizing two non-toxic components, a photo-activating liquid and a LED light source that selectively target and abolish cariogenic bacteria and periodontal pathogens . The usage of PAD in caries management can eradicate residual bacteria in soft dentin, reassures rapid healing and improve the prognosis of treatment .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| photo-activated oral disinfection | Experimental | Device: photo-activated oral disinfectionphoto-activated oral disinfection is an advanced technology utilizing two non-toxic components, a photo-activating liquid and a LED light source that selectively target and abolish cariogenic bacteria and periodontal pathogens |
| calcium hydroxide | Active comparator | Drug: Calcium HydroxideCalcium hydroxide is the gold standard for pulp capping, it permits reparative dentin bridge formation, maintains pulp vitality, protects the pulp against harmful stimuli and has antimicrobial effect |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Restorable lower first permanent molars with deep carious lesions
- Absence of clinical signs and symptoms of irreversible pulpitis, fistula, swelling in periodontal tissues or abnormal tooth mobility
- Absence of adverse radiographic findings
- Compliant patient/parent and (e) Absence of any systemic disease.
Key exclusion criteria (1 listed)
- Previously restored teeth .
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 |
|---|---|---|
| photo-activated oral disinfectionAlso: PADApplication of PAD solution using disposable tip with agitation of the solution for 60 seconds using a brush; Placement of the light disposable tip in center of lesion and holding it just above the surface; Activation of the red light for 60 seconds; (h)Sealing the cavity with glass ionomer and then filling with composite resin as a final restoration | Device | photo-activated oral disinfection |
| Calcium HydroxideAlso: Ca(OH)2calcium hydroxide( Dycal ® Dentsply Caulk )was applied using calcium hydroxide applicator followed by glass ionomer and then composite resin as a final restoration | Drug | calcium hydroxide |
Primary outcome
postoperative pain: verbal rating scale
Time frame: 2 months
categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome
postoperative pain: verbal rating scale
Time frame: 6 months
categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome
postoperative pain: verbal rating scale
Time frame: 9 months
categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome
postoperative pain: verbal rating scale
Time frame: 12 months
categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome.
5 secondary outcomes
Presence or absence of pain on percussion
Time frame: 2,6,9 and 12 months
Swelling
Time frame: 2,6,9 and 12 months
Sinus or fistula
Time frame: 2,6,9 and 12 months
Adverse radiographic findings
Time frame: 2,6,9 and 12 months
Thickness of newly formed dentin
Time frame: 2,6,9 and 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 15 Aug 2018.
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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.
Ahmed M Abd Alsamad, PHD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing photo-activated oral disinfection and Calcium Hydroxide in people with Deep Caries, 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 4 inclusion and 1 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 15 Aug 2018. 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.
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?
postoperative pain: verbal rating scale (time frame: 2 months). 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 Aug 2018.