MTANCT07894523
Clinical and Radiographic Evaluation of Dia-Root Bio MTA for Indirect Pulp Capping in Young Permanent Molars
A study testing Dia-Root Bio MTA Indirect Pulp Capping and MTA Plus Indirect Pulp Capping in people with MTA and Pulp Caping, run by Tanta University at 1 site in Egypt.
Trial summary
This split-mouth randomized controlled clinical trial evaluates and compares the clinical and radiographic success of Dia-Root Bio MTA versus conventional Mineral Trioxide Aggregate (MTA Plus) as indirect pulp capping (IPC) materials in young permanent molars. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- MTA, Pulp Caping, Permanent Molars
- What is being tested?
- Dia-Root Bio MTA Indirect Pulp Capping and MTA Plus Indirect Pulp Capping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy cooperative children free from systemic diseases aged from 6 to 9 years.
- Asymptomatic restorable bilateral first permanent molars with deep carious occlusal lesions (ICDAS code 4, 5) with a positive response to vitality tests.
- Normal radiographic appearance (intact lamina dura, absence of internal and/or external root resorption, and no periapical radiolucency).
Who cannot join
- Signs and symptoms of irreversible pulpitis, such as spontaneous pain, pathological mobility, pain with percussion, fistula, or discoloration.
- Unrestorable molars
- Previously restored molars
- Periapical radiolucency or internal and/or external root resorption.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shrouk Hussein Mohammed Elbrolesy, master contact
Egypt1 site, 1 recruiting
- Recruiting
faculty of dentistry, Tanta university
Tanta
shaimaa eldesouky, assistant professor, 01008994242, shaimaaeldesouky@dent.tanta.edu.eg
About this study
Official title: Clinical and Radiographic Evaluation of DIA-ROOT BIO MTA as an Indirect Pulp Capping Agent in Young Permanent Molars
This split-mouth randomized controlled clinical trial evaluates and compares the clinical and radiographic success of Dia-Root Bio MTA versus conventional Mineral Trioxide Aggregate (MTA Plus) as indirect pulp capping (IPC) materials in young permanent molars.
Read the detailed description
Twenty pediatric patients aged 6 to 9 years with bilateral deeply carious mandibular first permanent molars requiring indirect pulp capping are enrolled (n = 40 molars total). Following selective caries removal to soft dentin and preservation of affected dentin, target molars are randomly allocated in a split-mouth design to receive either Dia-Root Bio MTA (Group I) or MTA Plus (Group II) capped with glass ionomer base and composite resin restorations. Postoperative clinical pain is tracked using a 4-point facial pain intensity scale over the first 48 hours. Clinical success (absence of tenderness, swelling, fistula, or pathological mobility) and radiographic parameters (dentine bridge/dentin thickness formation, radiodensity changes, and absence of root resorption) are evaluated at 3, 6, and 9 months post-operative.
- Conditions
- MTA, Pulp Caping, Permanent Molars, Radiographic Evaluation
- Being tested
- Dia-Root Bio MTA Indirect Pulp Capping, MTA Plus Indirect Pulp Capping
- Keywords
- Young Permanent Molars, DIA-ROOT BIO MTA, MTA, Indirect Pulp Capping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dia-Root Bio MTA Indirect Pulp CappingProcedure or surgery
Preparation: Administration of 4% Articaine local anesthesia with epinephrine, rubber dam isolation, high-speed cavity preparation to non-carious dentin at lateral walls, and selective excavation of soft carious dentin at the pulpal floor using a manual excavator (leaving firm affected dentin). Cavity flushed with saline for 10 seconds and air-dried.
Capping \& Restoration: Dia-Root Bio MTA mixed with sterile distilled water (0.225g : 0.5g powder ratio) for 30 seconds, placed over residual dentin at 3-4 mm thickness, and condensed with a moist cotton pellet. Cavity sealed immediately with glass ionomer cement base (Nova Glass) and restored with composite resin (Tetric N Ceram).
MTA Plus Indirect Pulp CappingProcedure or surgery
Preparation: Identical local anesthesia, rubber dam isolation, lateral wall caries excavation, and selective soft dentin excavation at the pulpal floor, saline flush, and air-drying.
Capping \& Restoration: MTA Plus mixed with sterile distilled water to putty consistency, placed over residual dentin at 3-4 mm thickness, condensed with a moist cotton pellet, sealed immediately with glass ionomer base, and restored with identical composite resin.
| Study group | Role | What they receive |
|---|---|---|
| Group I - Experimental Group (Dia-Root Bio MTA) | Experimental | Asymptomatic deep carious young permanent mandibular first molars treated with indirect pulp capping using Dia-Root Bio MTA paste prior to final composite restoration. Receives: Procedure: Dia-Root Bio MTA Indirect Pulp Capping |
| Group II - Active Comparator Group (MTA Plus) | Active comparator | Asymptomatic deep carious young permanent mandibular first molars treated with indirect pulp capping using MTA Plus prior to final composite restoration. Receives: Procedure: MTA Plus Indirect Pulp Capping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Clinical Success Rate
Binary clinical evaluation (Success/Failure) defined as the complete absence of clinical signs and symptoms of pulpal/periapical pathology:
Absence of tenderness to percussion or mastication.
Absence of gingival swelling, abscess, or fistulous tract.
Absence of pathological tooth mobility.
Measured: 3 months, 6 months, and 9 months post-operative.
Radiographic Success Rate and Dentin Bridge Formation
Radiographic evaluation on standardized digital periapical radiographs to verify:
Presence/increase in newly formed tertiary dentin thickness under the capping material.
Radiodensity changes of affected dentin at the pulpal floor. Complete absence of internal/external root resorption or periapical radiolucency.
Measured: Baseline (immediate post-operative), 3 months, 6 months, and 9 months post-operative.
Secondary outcomes (1)
Early Postoperative Pain Intensity
Postoperative pain self-reported by the child/parent using a standardized 4-point facial pain intensity rating scale categorized as:
- No pain
- Slight pain
- Moderate pain
- Severe pain
Measured: 6 hours, 12 hours, 24 hours, and 48 hours post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start2 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MTAStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shaban Mohamed El-desouky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894523
- Sponsor's protocol ID
- # PED-10-25-3456
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Llena C, Hernandez M, Melo M, Sanz JL, Forner L. Follow-up of patients subjected to direct and indirect pulp capping of young permanent teeth. A retrospective study. Clin Exp Dent Res. 2021 Aug;7(4):429-435. doi: 10.1002/cre2.362. Epub 2020 Dec 31.
PubMed 33382210Rahman B, Goswami M. Comparative Evaluation of Indirect Pulp Therapy in Young Permanent Teeth using Biodentine and Theracal: A Randomized Clinical Trial. J Clin Pediatr Dent. 2021 Jul 1;45(3):158-164. doi: 10.17796/1053-4625-45.3.3.
PubMed 34192759
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of DIA-ROOT BIO MTA as an Indirect Pulp Capping Agent in Young Permanent Molars
- ClinicalTrials.gov ID
- NCT07894523
- Acronym / sponsor ID
- # PED-10-25-3456
- Conditions
- MTA, Pulp Caping, Permanent Molars, Radiographic Evaluation
- Keywords
- Young Permanent Molars, DIA-ROOT BIO MTA, MTA, Indirect Pulp Capping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 2 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Oct 2026 (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 split-mouth randomized controlled clinical trial evaluates and compares the clinical and radiographic success of Dia-Root Bio MTA versus conventional Mineral Trioxide Aggregate (MTA Plus) as indirect pulp capping (IPC) materials in young permanent molars.
Detailed description
Twenty pediatric patients aged 6 to 9 years with bilateral deeply carious mandibular first permanent molars requiring indirect pulp capping are enrolled (n = 40 molars total). Following selective caries removal to soft dentin and preservation of affected dentin, target molars are randomly allocated in a split-mouth design to receive either Dia-Root Bio MTA (Group I) or MTA Plus (Group II) capped with glass ionomer base and composite resin restorations. Postoperative clinical pain is tracked using a 4-point facial pain intensity scale over the first 48 hours. Clinical success (absence of tenderness, swelling, fistula, or pathological mobility) and radiographic parameters (dentine bridge/dentin thickness formation, radiodensity changes, and absence of root resorption) are evaluated at 3, 6, and 9 months post-operative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I - Experimental Group (Dia-Root Bio MTA) | Experimental | Procedure: Dia-Root Bio MTA Indirect Pulp CappingAsymptomatic deep carious young permanent mandibular first molars treated with indirect pulp capping using Dia-Root Bio MTA paste prior to final composite restoration. |
| Group II - Active Comparator Group (MTA Plus) | Active comparator | Procedure: MTA Plus Indirect Pulp CappingAsymptomatic deep carious young permanent mandibular first molars treated with indirect pulp capping using MTA Plus prior to final composite restoration. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy cooperative children free from systemic diseases aged from 6 to 9 years.
- Asymptomatic restorable bilateral first permanent molars with deep carious occlusal lesions (ICDAS code 4, 5) with a positive response to vitality tests.
- Normal radiographic appearance (intact lamina dura, absence of internal and/or external root resorption, and no periapical radiolucency).
Key exclusion criteria (4 listed)
- Signs and symptoms of irreversible pulpitis, such as spontaneous pain, pathological mobility, pain with percussion, fistula, or discoloration.
- Unrestorable molars
- Previously restored molars
- Periapical radiolucency or internal and/or external root resorption.
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 |
|---|---|---|
| Dia-Root Bio MTA Indirect Pulp CappingPreparation: Administration of 4% Articaine local anesthesia with epinephrine, rubber dam isolation, high-speed cavity preparation to non-carious dentin at lateral walls, and selective excavation of soft carious dentin at the pulpal floor using a manual excavator (leaving firm affected dentin). Cavity flushed with saline for 10 seconds and air-dried. Capping \& Restoration: Dia-Root Bio MTA mixed with sterile distilled water (0.225g : 0.5g powder ratio) for 30 seconds, placed over residual dentin at 3-4 mm thickness, and condensed with a moist cotton pellet. Cavity sealed immediately with glass ionomer cement base (Nova Glass) and restored with composite resin (Tetric N Ceram). | Procedure or surgery | Group I - Experimental Group (Dia-Root Bio MTA) |
| MTA Plus Indirect Pulp CappingPreparation: Identical local anesthesia, rubber dam isolation, lateral wall caries excavation, and selective soft dentin excavation at the pulpal floor, saline flush, and air-drying. Capping \& Restoration: MTA Plus mixed with sterile distilled water to putty consistency, placed over residual dentin at 3-4 mm thickness, condensed with a moist cotton pellet, sealed immediately with glass ionomer base, and restored with identical composite resin. | Procedure or surgery | Group II - Active Comparator Group (MTA Plus) |
Primary outcome
Cumulative Clinical Success Rate
Time frame: 3 months, 6 months, and 9 months post-operative.
Binary clinical evaluation (Success/Failure) defined as the complete absence of clinical signs and symptoms of pulpal/periapical pathology: Absence of tenderness to percussion or mastication. Absence of gingival swelling, abscess, or fistulous tract. Absence of pathological tooth mobility.
Radiographic Success Rate and Dentin Bridge Formation
Time frame: Baseline (immediate post-operative), 3 months, 6 months, and 9 months post-operative.
Radiographic evaluation on standardized digital periapical radiographs to verify: Presence/increase in newly formed tertiary dentin thickness under the capping material. Radiodensity changes of affected dentin at the pulpal floor. Complete absence of internal/external root resorption or periapical radiolucency.
1 secondary outcome
Early Postoperative Pain Intensity
Time frame: 6 hours, 12 hours, 24 hours, and 48 hours post-procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Results publication: PubMed 33382210Llena C, Hernandez M, Melo M, Sanz JL, Forner L. Follow-up of patients subjected to direct and indirect pulp capping of young permanent teeth. A retrospective study. Clin Exp Dent Res. 2021 Aug;7(4):429-435. doi: 10.1002/cre2.362. Epub 2020 Dec 31.
- Results publication: PubMed 34192759Rahman B, Goswami M. Comparative Evaluation of Indirect Pulp Therapy in Young Permanent Teeth using Biodentine and Theracal: A Randomized Clinical Trial. J Clin Pediatr Dent. 2021 Jul 1;45(3):158-164. doi: 10.17796/1053-4625-45.3.3.
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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.
Shrouk Hussein Mohammed Elbrolesy, master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dia-Root Bio MTA Indirect Pulp Capping and MTA Plus Indirect Pulp Capping in people with MTA and Pulp Caping, run by Tanta 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 3 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shaimaa eldesouky, assistant professor (01008994242, shaimaaeldesouky@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Clinical Success Rate (time frame: 3 months, 6 months, and 9 months post-operative.). 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?
On the ClinicalTrials.gov record for NCT07894523, which also lists 2 linked publications.
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 26 Oct 2026.