Indirect Pulp TreatmentNCT04770792
The Use of 2% Chlorhexidine Gluconate With Mineral Trioxide Aggregate in Indirect Pulp Treatment of Primary Molars
A study testing 2% chlorhexidine gluconate with mineral trioxide aggregate. and Mineral trioxide aggregate. in people with Indirect Pulp Treatment, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The aim of this study was to compare the clinical and radiographic success rates of indirect pulp treatment (IPT) performed by combining 2% chlorhexidine gluconate with mineral trioxide aggregate (MTA) versus IPT performed with MTA in children's vital 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
- Indirect Pulp Treatment
- What is being tested?
- 2% chlorhexidine gluconate with mineral trioxide aggregate. and Mineral trioxide aggregate.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 6 Apr 2019to 8 Jun 2021
- 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
- Patient inclusion criteria:
- 4-8 years old.
- Healthy.
- Cooperative.
- Had at least two first primary molars or two second primary molars with deep occlusal or proximal caries not approaching the pulp indicated for IPT.
- Teeth inclusion criteria:
Show all 15Show fewer
- No spontaneous pain.
- No pain on palpation or percussion.
- No signs of fistula or abscess.
- No abnormal mobility.
- No radiolucency at the periapical or interradicular areas.
- No loss of lamina dura.
- No radiographic signs of internal resorption.
- Sufficient tooth structure allowing placement of rubber dam.
- Not expected to exfoliate within 1 year.
Who cannot join
- Spontaneous pain.
- Pain on palpation or percussion.
- Signs of fistula or abscess.
- Presence of abnormal mobility.
- Radiolucency at the periapical or interradicular areas.
- Loss of lamina dura.
Show all 9Show fewer
- Radiographic signs of internal resorption.
- No sufficient tooth structure allowing placement of rubber dam.
- Expected to exfoliate within 1 year.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Abdulaziz University
Jeddah, Mecca Region, Jeddah 21589
About this study
Official title: The Use of 2% Chlorhexidine Gluconate With Mineral Trioxide Aggregate in Indirect Pulp Treatment of Primary Molars: A Randomized Controlled Clinical Trial
The aim of this study was to compare the clinical and radiographic success rates of indirect pulp treatment (IPT) performed by combining 2% chlorhexidine gluconate with mineral trioxide aggregate (MTA) versus IPT performed with MTA in children's vital primary molars. A randomized, split-mouth design including 40 children aged 4-8 years was implemented. The study sample composed of 80 primary molars with deep carious lesions. Each child had 1 pair, one tooth from each pair was allocated randomly either to the 2% chlorhexidine gluconate/MTA group or the MTA group. All teeth were restored with stainless steel crowns. Follow-up is carried out to evaluate the teeth clinically and radiographically.
Read the detailed description
A double blinded, randomized, controlled clinical trial was performed in a split-mouth design. Eighty primary molars in forty subjects were randomly allocated that each subject had one tooth treated with 2% chlorhexidine gluconate and MTA (experimental group), and the other tooth treated with only MTA (control group).
The study was held at King Abdulaziz University Dental Hospital (KAUDH), Jeddah. Forty healthy children with the age range 4- to 8-year-old were included. Each patient had at least two first primary molars or two second primary molars with deep occlusal or proximal caries not approaching the pulp indicated for IPT.
Preoperative periapical radiographs of the teeth considered for treatment in the study were made using extension cone paralleling technique in the x ray machine.
The procedure was performed in two visits by one operator to allow for the setting of MTA. Stainless steel crowns were used as final restorations.
- Conditions
- Indirect Pulp Treatment
- Being tested
- 2% chlorhexidine gluconate with mineral trioxide aggregate., Mineral trioxide aggregate.
- Keywords
- Indirect pulp treatment, Deep caries, Primary molars, Mineral trioxide aggregate, 2% chlorhexidine gluconate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% chlorhexidine gluconate with mineral trioxide aggregate.Other
2% chlorhexidine gluconate with mineral trioxide aggregate.
Mineral trioxide aggregate.Other
Mineral trioxide aggregate.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 2% chlorhexidine gluconate with mineral trioxide aggregate. Receives: Other: 2% chlorhexidine gluconate with mineral trioxide aggregate. |
| Control group | Active comparator | Mineral trioxide aggregate. Receives: Other: Mineral trioxide aggregate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Recording Sheet for Intraoral Clinical Examination
Data sheet for recording the clinical outcome criteria obtained by intraoral clinical examination is filled by the investigators. The data sheet includes information regarding the presence or absence of the following:
- Spontaneous pain.
- Pain on percussion.
- Signs of abscess or fistula.
- Abnormal mobility. The response for each point is interpreted in the form by either "yes" or "no".
Measured: 12 months
Data Recording Sheet for Periapical Radiographic Evaluation
Data sheet for recording the radiographic outcome criteria obtained from periapical radiograph is filled by the investigators. The data sheet includes information regarding the presence or absence of the following:
- Radiolucency at the periapical or interradicular areas.
- Loss of lamina dura.
- Signs of internal root resorption.
- Signs of external pathologic root resorption.
- Normal root resorption accompanying the exfoliation process. The response for each point is interpreted in the form by either "yes" or "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.
- First posted25 Feb 2021
- Study start6 Apr 2019
- Primary completion31 Dec 2020
- Study completion8 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indirect Pulp TreatmentStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afnan Saber, King Abdulaziz University
- Investigators
- Afnan M Saber, MSc, Principal investigator, Phd student at Pediatric Dentistry Department, Faculty of Dentistry, King Abdulaziz University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770792
- Sponsor's protocol ID
- ASaber
- Status last verified
- Sep 2021
- First submitted
- 9 Feb 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of 2% Chlorhexidine Gluconate With Mineral Trioxide Aggregate in Indirect Pulp Treatment of Primary Molars: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04770792
- Acronym / sponsor ID
- ASaber
- Conditions
- Indirect Pulp Treatment
- Keywords
- Indirect pulp treatment, Deep caries, Primary molars, Mineral trioxide aggregate, 2% chlorhexidine gluconate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 6 Apr 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 25 Feb 2021 (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.
The aim of this study was to compare the clinical and radiographic success rates of indirect pulp treatment (IPT) performed by combining 2% chlorhexidine gluconate with mineral trioxide aggregate (MTA) versus IPT performed with MTA in children's vital primary molars. A randomized, split-mouth design including 40 children aged 4-8 years was implemented. The study sample composed of 80 primary molars with deep carious lesions. Each child had 1 pair, one tooth from each pair was allocated randomly either to the 2% chlorhexidine gluconate/MTA group or the MTA group. All teeth were restored with stainless steel crowns. Follow-up is carried out to evaluate the teeth clinically and radiographically.
Detailed description
A double blinded, randomized, controlled clinical trial was performed in a split-mouth design. Eighty primary molars in forty subjects were randomly allocated that each subject had one tooth treated with 2% chlorhexidine gluconate and MTA (experimental group), and the other tooth treated with only MTA (control group).
The study was held at King Abdulaziz University Dental Hospital (KAUDH), Jeddah. Forty healthy children with the age range 4- to 8-year-old were included. Each patient had at least two first primary molars or two second primary molars with deep occlusal or proximal caries not approaching the pulp indicated for IPT.
Preoperative periapical radiographs of the teeth considered for treatment in the study were made using extension cone paralleling technique in the x ray machine.
The procedure was performed in two visits by one operator to allow for the setting of MTA. Stainless steel crowns were used as final restorations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: 2% chlorhexidine gluconate with mineral trioxide aggregate.2% chlorhexidine gluconate with mineral trioxide aggregate. |
| Control group | Active comparator | Other: Mineral trioxide aggregate.Mineral trioxide aggregate. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- 4-8 years old.
- Healthy.
- Cooperative.
- Had at least two first primary molars or two second primary molars with deep occlusal or proximal caries not approaching the pulp indicated for IPT.
- No spontaneous pain.
Key exclusion criteria (9 listed)
- Spontaneous pain.
- Pain on palpation or percussion.
- Signs of fistula or abscess.
- Presence of abnormal mobility.
- Radiolucency at the periapical or interradicular areas.
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 |
|---|---|---|
| 2% chlorhexidine gluconate with mineral trioxide aggregate.2% chlorhexidine gluconate with mineral trioxide aggregate. | Other | Experimental group |
| Mineral trioxide aggregate.Mineral trioxide aggregate. | Other | Control group |
Primary outcome
Data Recording Sheet for Intraoral Clinical Examination
Time frame: 12 months
Data sheet for recording the clinical outcome criteria obtained by intraoral clinical examination is filled by the investigators. The data sheet includes information regarding the presence or absence of the following: 1. Spontaneous pain. 2. Pain on percussion. 3. Signs of abscess or fistula. 4. Abnormal mobility. The response for each point is interpreted in the form by either "yes" or "no".
Data Recording Sheet for Periapical Radiographic Evaluation
Time frame: 12 months
Data sheet for recording the radiographic outcome criteria obtained from periapical radiograph is filled by the investigators. The data sheet includes information regarding the presence or absence of the following: 1. Radiolucency at the periapical or interradicular areas. 2. Loss of lamina dura. 3. Signs of internal root resorption. 4. Signs of external pathologic root resorption. 5. Normal root resorption accompanying the exfoliation process. The response for each point is interpreted in the form by either "yes" or "no".
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 16 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Indirect Pulp Treatment
Not yet recruitingPhase 2
Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Platelet Rich Fibrin Versus Mineral Trioxide Aggregate in Deep Carious Molars: a Randomized Controlled Trial
Dental Caries, Pulp Caping
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.
Afnan M Saber, MSc principal investigator
Phd student at Pediatric Dentistry Department, Faculty of Dentistry, King Abdulaziz 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 2% chlorhexidine gluconate with mineral trioxide aggregate. and Mineral trioxide aggregate. in people with Indirect Pulp Treatment, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 15 inclusion and 9 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 16 Sep 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 Saudi Arabia. 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?
Data Recording Sheet for Intraoral Clinical Examination (time frame: 12 months). The study lists 2 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 16 Sep 2021; AzTrials last refreshed its copy on 26 Oct 2026.