Hypomineralization, ToothNCT05816096
ART Compared to the Hall Technique for Management HSPM
A study testing Hall technique and ART in people with Hypomineralization, Tooth, run by Latakia University at 1 site in Syria.
Trial summary
Aims: Evaluation of treatment success on HSPM-affected molars after ART and Hall technique. comparison of pain during treatment with ART and Hall technique in HSPM. comparison of child and parent satisfaction with restorations used by ART and Hall technique. Read more about this study
- Who is it for?
- Ages 3 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypomineralization, Tooth
- What is being tested?
- Hall technique and ART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSyria
- Study dates
- 26 Mar 2023to 30 Apr 2024
- 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 3 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Absolute positive, positive or negative behavior according to the Frankel Scale.
- Healthy, both physically and mentally.
- Do not take medications that interfere with the assessment of pain within 24 hours prior to treatment.
- A child with HSPM-affected primary second molars on the right and left side in one jaw.
- The HSPM affected teeth from 2-6 degree in Ghanim scale.
- Teeth with atypical carious lesions.
- Teeth with post-eruption destroyed
- The presence of a clear, intact dentinal bridge between the caries and pulp radially.
Who cannot join
- Allergy to the substances used in restoration.
- Presence of general or developmental medical conditions.
- Teeth with pulpitis inflammation or apical lesion or non-restorable.
- Teeth closed to being replaced.
Trial locations and contacts
1 site in 1 country.
Syria1 site, 1 recruiting
- Recruiting
Tishreen University
Latakia
Nabih Raslan, Dr, 00963999140762, Raslan.nabih@tishreen.edu.sy
Aya Adl, Dr, 00963965334652, Ayoosh.sy994@gmail.com
About this study
Official title: Atraumatic Restoration Treatment Compared to the Hall Technique for Management Hypomineralization Second Primary Molars
Aims: Evaluation of treatment success on HSPM-affected molars after ART and Hall technique.
comparison of pain during treatment with ART and Hall technique in HSPM. comparison of child and parent satisfaction with restorations used by ART and Hall technique.
Design: A randomized, controlled, crossover clinical study including thirty children.
Read the detailed description
Background and Aims:
Despite the widespread prevalence of HSPM:
there are no comparative studies yet between ART and Hall technique in the restoration of HSPM.
there are no studies yet on the success of ART in the treatment of HSPM.
Design:
A randomized, controlled, crossover clinical study including thirty children Each child will apply both of ART and Hall technique to him.
- Conditions
- Hypomineralization, Tooth
- Being tested
- Hall technique, ART
- Keywords
- ART, Hall technique, HSPM, Children, Restoration
- Medical subject headings
- Dental Enamel Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hall techniqueCombination product
Also called A
The child will be placed to them SSC on one of their HSPM affected teeth. Pain during treatment will be assessed using the FLACC scale and satisfaction the child and parent will be evaluated using likert scale after the treatment immediately and after one month and evaluate the success restoration adapted from Innes et al. after 3_6_9_12 month.
ARTCombination product
Also called B
The child will be restored to them one of their HSPM affected teeth by GIC. Pain during treatment will be assessed using the FLACC scale and satisfaction the child and parent will be evaluated using likert scale after the treatment immediately and after one month and evaluate the success restoration adapted from Innes et al. after 3_6_9_12 month.
| Study group | Role | What they receive |
|---|---|---|
| A (Hall Technique) | Active comparator | 31 child will be treated by one performed metal crown using Hall technique on one of HSPM affected tooth.
The correct size of SSC for tooth will be selected. Use the separating rubber if necessary. Dried the tooth and cemented the SSC by glass ionomer luting cement and used finger pressure to seat the crown and instructed the child to bite down on the SSC.
Half of the total number of children will received performed metal crown at the first by divided them randomly to the two groups using the randomization table. Receives: Combination Product: Hall technique |
| B (ART) | Experimental | 31 child will be treated by Bulk fill glass hybrid restorative system (Equia Forte HT®) using Atraumatic restoration treatment on one of HSPM affected tooth.
Isolate the tooth by cotton rolls, remove the carious soft tissue using hand instrument excavators then condition the cavity with a polyacrylic acid solution 11.5% for 10 seconds. After washed and dried the cavity insert the GIC and protect it by Equia forte coat.
Half of the total number of children will received ART at the first by divided them randomly to the two groups using the randomization table. Receives: Combination Product: ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental pain assessed by FLACC scale
Evaluated by outcome assessor using the faces, legs, activity, cry, consolability behavioral rating scale (FLACC scale) a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability, which are each assigned a score of 0,1 or2.
Total score of scale is summed in range 0 to10, where:0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.
Measured: During the placement of the restoration
Secondary outcomes (4)
Child Satisfaction with the restoration assessed by the Likert scale
Self-assessment by the children using Likert scale which is a psychometric scale has five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied)
Measured: Immediately after the placement of the restoration
Parent Satisfaction with the restoration assessed by the Likert scale
Self-assessment by the parent using Likert scale which is a psychometric scale has five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied)
Measured: Immediately after the placement of the restoration after asking the child
Child Satisfaction with the restoration assessed by the Likert scale
Self-assessment by the children using Likert scale which is a psychometric scale has five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied)
Measured: After one month from treatment
Parent Satisfaction with the restoration assessed by the Likert scale
Self-assessment by the parent using Likert scale which is a psychometric scale has a five responses (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied)
Measured: After one month from treatment after asking the child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start26 Mar 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypomineralization, ToothStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- A randomized, controlled, crossover clinical study, comparison of ART and Hall Technique.
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nabih Raslan, Dr, Study chair, Latakia UniversityAya Adl, Dr, Principal investigator, Latakia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816096
- Sponsor's protocol ID
- Restoration for HSPM
- Status last verified
- Apr 2023
- First submitted
- 28 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Up to date, there is no decision about IPD sharing
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atraumatic Restoration Treatment Compared to the Hall Technique for Management Hypomineralization Second Primary Molars
- ClinicalTrials.gov ID
- NCT05816096
- Acronym / sponsor ID
- Restoration for HSPM
- Conditions
- Hypomineralization, Tooth
- Keywords
- ART, Hall technique, HSPM, Children, Restoration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 26 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 18 Apr 2023 (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.
Aims: Evaluation of treatment success on HSPM-affected molars after ART and Hall technique.
comparison of pain during treatment with ART and Hall technique in HSPM. comparison of child and parent satisfaction with restorations used by ART and Hall technique.
Design: A randomized, controlled, crossover clinical study including thirty children.
Detailed description
Background and Aims:
Despite the widespread prevalence of HSPM:
there are no comparative studies yet between ART and Hall technique in the restoration of HSPM.
there are no studies yet on the success of ART in the treatment of HSPM.
Design:
A randomized, controlled, crossover clinical study including thirty children Each child will apply both of ART and Hall technique to him.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, controlled, crossover clinical study, comparison of ART and Hall Technique.
| Arm | Type | Receives |
|---|---|---|
| A (Hall Technique) | Active comparator | Combination Product: Hall technique31 child will be treated by one performed metal crown using Hall technique on one of HSPM affected tooth. The correct size of SSC for tooth will be selected. Use the separating rubber if necessary. Dried the tooth and cemented the SSC by glass ionomer luting cement and used finger pressure to seat the crown and instructed the child to bite down on the SSC. Half of the total number of children will received performed metal crown at the first by divided them randomly to the two groups using the randomization table. |
| B (ART) | Experimental | Combination Product: ART31 child will be treated by Bulk fill glass hybrid restorative system (Equia Forte HT®) using Atraumatic restoration treatment on one of HSPM affected tooth. Isolate the tooth by cotton rolls, remove the carious soft tissue using hand instrument excavators then condition the cavity with a polyacrylic acid solution 11.5% for 10 seconds. After washed and dried the cavity insert the GIC and protect it by Equia forte coat. Half of the total number of children will received ART at the first by divided them randomly to the two groups using the randomization table. |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Absolute positive, positive or negative behavior according to the Frankel Scale.
- Healthy, both physically and mentally.
- Do not take medications that interfere with the assessment of pain within 24 hours prior to treatment.
- A child with HSPM-affected primary second molars on the right and left side in one jaw.
- The HSPM affected teeth from 2-6 degree in Ghanim scale.
Key exclusion criteria (4 listed)
- Allergy to the substances used in restoration.
- Presence of general or developmental medical conditions.
- Teeth with pulpitis inflammation or apical lesion or non-restorable.
- Teeth closed to being replaced.
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 |
|---|---|---|
| Hall techniqueAlso: AThe child will be placed to them SSC on one of their HSPM affected teeth. Pain during treatment will be assessed using the FLACC scale and satisfaction the child and parent will be evaluated using likert scale after the treatment immediately and after one month and evaluate the success restoration adapted from Innes et al. after 3_6_9_12 month. | Combination product | A (Hall Technique) |
| ARTAlso: BThe child will be restored to them one of their HSPM affected teeth by GIC. Pain during treatment will be assessed using the FLACC scale and satisfaction the child and parent will be evaluated using likert scale after the treatment immediately and after one month and evaluate the success restoration adapted from Innes et al. after 3_6_9_12 month. | Combination product | B (ART) |
Primary outcome
Dental pain assessed by FLACC scale
Time frame: During the placement of the restoration
Evaluated by outcome assessor using the faces, legs, activity, cry, consolability behavioral rating scale (FLACC scale) a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability, which are each assigned a score of 0,1 or2. Total score of scale is summed in range 0 to10, where:0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.
4 secondary outcomes
Child Satisfaction with the restoration assessed by the Likert scale
Time frame: Immediately after the placement of the restoration
Parent Satisfaction with the restoration assessed by the Likert scale
Time frame: Immediately after the placement of the restoration after asking the child
Child Satisfaction with the restoration assessed by the Likert scale
Time frame: After one month from treatment
Parent Satisfaction with the restoration assessed by the Likert scale
Time frame: After one month from treatment after asking the child
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided. Up to date, there is no decision about IPD sharing
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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.
Nabih Raslan, Dr study chair
Latakia University
Aya Adl, Dr principal investigator
Latakia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hall technique and ART in people with Hypomineralization, Tooth, run by Latakia University at 1 site in Syria.
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 8 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. 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 Syria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nabih Raslan, Dr (00963999140762, Raslan.nabih@tishreen.edu.sy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental pain assessed by FLACC scale (time frame: During the placement of the restoration). 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 18 Apr 2023.