Vital Pulp Therapy in Young Permanent ToothMTA/CBCTNCT07336498
Clinical Evaluation and Cone Beam Computed Tomography Analysis of Different Biomaterials for Apexogenesis of Immature Permanent Molars
A study testing Vital pulp therapy of immature permanent teeth in people with Vital Pulp Therapy in Young Permanent Tooth, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The present study will be conducted to clinically evaluation and cone beam computed tomography analysis of amniotic membrane, putty mineral trioxide aggregate and biodentine as therapeutic agents for apexogenesis of immature permanent molars Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Vital Pulp Therapy in Young Permanent Tooth
- What is being tested?
- Vital pulp therapy of immature permanent teeth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Apr 2026
- 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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy patients without any systemic disease aged 7 to 10 years old.
- Vital immature permanent molars with deep carious lesions.
- Restorable tooth
- No clinical signs and symptoms of irreversible pulpitis including spontaneous pain, tenderness to percussion, swelling or sinus tract.
- No radiographic evidence of periapical abscess, internal or external resorption.
Who cannot join
- Patients with known allergies to any of the dental materials to be used.
- Bleeding could not be controlled within 5 minutes after complete pulpotomy
- Teeth with root fractures
- Carious furcation involvement
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Al-Azhar University, Cairo (Boys Branch)
Cairo
About this study
Official title: Clinical Evaluation and Cone Beam Computed Tomography Analysis of Amniotic Membrane, Putty Mineral Trioxide Aggregate and Biodentine as Therapeutic Agents for Apexogenesis of Immature Permanent Molars: A Randomized Clinical Trial
The present study will be conducted to clinically evaluation and cone beam computed tomography analysis of amniotic membrane, putty mineral trioxide aggregate and biodentine as therapeutic agents for apexogenesis of immature permanent molars
Read the detailed description
An immature permanent tooth is defined as, a newly erupted permanent tooth with incomplete root apex formation. Since root development is completed in 2-3 years after tooth eruption into the oral cavity, loss of pulp vitality in the immature permanent tooth affected by caries, traumatic injury, or other causes creates major problems. The primary goal of pulp therapy is to maintain the integrity of the teeth while maintaining the vitality of the pulp, especially in young permanent teeth with immature roots to enhance root dentin formation. An increasingly popular therapy option for pulp damage in immature permanent molars is apexogenesis. Vital pulp therapy involves the complete removal of the coronal pulp and the placement of an acceptable material into the pulp chamber. With the invention of calcium silicate material namely mineral trioxide aggregate (MTA), it became preferred to calcium hydroxide in the treatment of exposed pulp. MTA demonstrated excellent biocompatibility, low solubility, outstanding sealing properties and antibacterial effect. However, MTA has some limitations regarding the long setting time and difficult handling. Premixed calcium silicate cements were developed to facilitate manipulation with no need for mixing, such as using the putty formulation which allows better handling with a thicker consistency Additionally, Biodentine was introduced as a tricalcium silicate-based bioceramic, with comparable physical properties to dentine, thus, it is also called dentine replacement material and has applications like those of MTA. Considering the limitations of MTA, biodentine has been developed with enhanced physicochemical properties such as a fast-setting time with an initial setting time between 9 and 12 minutes due to the presence of calcium chloride. Its short setting time allows restoration to be made in one session with easier chairside handling than MTA. Recently, novel biologically based material has been developed from the innermost layer of the placenta with highly rich stem cell reservoirs and is called amniotic membrane. The amniotic membrane is rich in growth factors, various types of collagens (such as types I, III, IV, V, and VII), along with proteoglycans, elastin and hyaluronic acid. It possesses a range of beneficial properties, including anti-inflammatory, antimicrobial and analgesic which make it a unique option for wound healing, providing a supportive environment that promotes the survival and proliferation of mesenchymal progenitor cells. In dentistry, researchers supported its application in regenerative endodontic therapy by providing a growth factors that promote stem cell growth and formation of a new dentine-pulp complex. Therefore, in the present study, clinical and radiographic evaluation will be done to assess the effectiveness of different biomaterials in managing immature permanent tooth with pulp exposure.
- Being tested
- Vital pulp therapy of immature permanent teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital pulp therapy of immature permanent teethProcedure or surgery
Conventional access cavity will be done with a high-speed bur using copious water spray. The coronal pulp amputation will be performed using a sharp spoon excavator. In order to achieve hemostasis sterilized cotton pellet moistened with sterile saline will be placed over the pulp's stumps for 5 minutes, followed by application of the therapeutic agent. The prepared cavities of all molars will be sealed with a layer of glass ionomer over the therapeutic agents and subsequently will be covered with composite resin restoration.
| Study group | Role | What they receive |
|---|---|---|
| Biodentine will be placed directly in the pulp chamber | Experimental | Not described Receives: Procedure: Vital pulp therapy of immature permanent teeth |
| Previously trimmed amniotic membrane will be placed directly in the pulp chamber | Experimental | Not described Receives: Procedure: Vital pulp therapy of immature permanent teeth |
| Putty MTA will be placed directly in the pulp chamber | Other | Not described Receives: Procedure: Vital pulp therapy of immature permanent teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes
Clinical assessment of the treated immature molars in each follow up period as follow:
- Presence or Absence of pain or sensitivity to percussion.
- Presence or absence of any evidence of swelling, or sinus tract.
- Presence or absence of excessive mobility of the treated teeth .
Measured: Base line, 7 days, 3 months, 6 months , 12 months
Secondary outcomes (3)
Radiographic assessment of root length by CBCT
The CBCT scanning was performed immediately after treatment to serve as the baseline and at 12 months follow-up periods to evaluate changes in the root for each tooth in all groups.
Root length: the sagittal section was used to measure the root length for each root using the CBCT ruler to draw a line from the center point of the line connecting CEJ to the most apical point in the center of the root apex.
the percentage of increase in root length of the immature permanent molar was calculated by the following formula: (12 months value-baseline value)/(Preoperative value) ×100
Measured: Baseline (immediately post-operative ) and 12 months post-operative
Radiographic assessment of diameter of apical foramen by CBCT
At the most apical point buccolingually in the sagittal view of the CBCT, the diameter of the apical foramen was measured using the CBCT ruler for each root of the immature permanent tooth. The percentage reduction of the apical diameter was calculated using this formula:
(baseline value-12 months value)/(Preoperative value)×100
Measured: Baseline (immediately post-operative) and 12 months post-operative)
Radiographic assessment of radiographic root area by CBCT
Using the CBCT polygon selection tool at the sagittal section and below a straight line marking the cementoenamel junction, the root area was outlined from the surrounding periodontal environment. The pulp space area was then calculated using the same technique, tracing the reference points around the pulp space with the polygon tool. Finally, the pulp space area was subtracted from the outer root area to determine the radiographic root area. The percentage of increase in radiographic root area of the immature permanent molar was calculated by the following formula:
(12 months value-baseline value)/(Preoperative value) ×100
Measured: Baseline(immediately post-operative) and at 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 2026 (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 Vital Pulp Therapy in Young Permanent ToothStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohamed Ezz Eldeen Ghareep, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336498
- Sponsor's protocol ID
- EC 1163/6935
- Acronym
- MTA/CBCT
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Duncan HF, Nagendrababu V, El-Karim IA, Dummer PMH. Outcome measures to assess the effectiveness of endodontic treatment for pulpitis and apical periodontitis for use in the development of European Society of Endodontology (ESE) S3 level clinical practice guidelines: a protocol. Int Endod J. 2021 May;54(5):646-654. doi: 10.1111/iej.13501. Epub 2021 Mar 15.
PubMed 33630330Dentistry AAoP. Pulp therapy for primary and immature permanent teeth. The Reference Manual of Pediatric Dentistry Chicago, Ill: American Academy of Pediatric Dentistry. 2021;399407.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation and Cone Beam Computed Tomography Analysis of Amniotic Membrane, Putty Mineral Trioxide Aggregate and Biodentine as Therapeutic Agents for Apexogenesis of Immature Permanent Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07336498
- Acronym / sponsor ID
- MTA/CBCT / EC 1163/6935
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 13 Jan 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.
The present study will be conducted to clinically evaluation and cone beam computed tomography analysis of amniotic membrane, putty mineral trioxide aggregate and biodentine as therapeutic agents for apexogenesis of immature permanent molars
Detailed description
An immature permanent tooth is defined as, a newly erupted permanent tooth with incomplete root apex formation. Since root development is completed in 2-3 years after tooth eruption into the oral cavity, loss of pulp vitality in the immature permanent tooth affected by caries, traumatic injury, or other causes creates major problems. The primary goal of pulp therapy is to maintain the integrity of the teeth while maintaining the vitality of the pulp, especially in young permanent teeth with immature roots to enhance root dentin formation. An increasingly popular therapy option for pulp damage in immature permanent molars is apexogenesis. Vital pulp therapy involves the complete removal of the coronal pulp and the placement of an acceptable material into the pulp chamber. With the invention of calcium silicate material namely mineral trioxide aggregate (MTA), it became preferred to calcium hydroxide in the treatment of exposed pulp. MTA demonstrated excellent biocompatibility, low solubility, outstanding sealing properties and antibacterial effect. However, MTA has some limitations regarding the long setting time and difficult handling. Premixed calcium silicate cements were developed to facilitate manipulation with no need for mixing, such as using the putty formulation which allows better handling with a thicker consistency Additionally, Biodentine was introduced as a tricalcium silicate-based bioceramic, with comparable physical properties to dentine, thus, it is also called dentine replacement material and has applications like those of MTA. Considering the limitations of MTA, biodentine has been developed with enhanced physicochemical properties such as a fast-setting time with an initial setting time between 9 and 12 minutes due to the presence of calcium chloride. Its short setting time allows restoration to be made in one session with easier chairside handling than MTA. Recently, novel biologically based material has been developed from the innermost layer of the placenta with highly rich stem cell reservoirs and is called amniotic membrane. The amniotic membrane is rich in growth factors, various types of collagens (such as types I, III, IV, V, and VII), along with proteoglycans, elastin and hyaluronic acid. It possesses a range of beneficial properties, including anti-inflammatory, antimicrobial and analgesic which make it a unique option for wound healing, providing a supportive environment that promotes the survival and proliferation of mesenchymal progenitor cells. In dentistry, researchers supported its application in regenerative endodontic therapy by providing a growth factors that promote stem cell growth and formation of a new dentine-pulp complex. Therefore, in the present study, clinical and radiographic evaluation will be done to assess the effectiveness of different biomaterials in managing immature permanent tooth with pulp exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biodentine will be placed directly in the pulp chamber | Experimental | Procedure: Vital pulp therapy of immature permanent teeth |
| Previously trimmed amniotic membrane will be placed directly in the pulp chamber | Experimental | Procedure: Vital pulp therapy of immature permanent teeth |
| Putty MTA will be placed directly in the pulp chamber | Other | Procedure: Vital pulp therapy of immature permanent teeth |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy patients without any systemic disease aged 7 to 10 years old.
- Vital immature permanent molars with deep carious lesions.
- Restorable tooth
- No clinical signs and symptoms of irreversible pulpitis including spontaneous pain, tenderness to percussion, swelling or sinus tract.
- No radiographic evidence of periapical abscess, internal or external resorption.
Key exclusion criteria (4 listed)
- Patients with known allergies to any of the dental materials to be used.
- Bleeding could not be controlled within 5 minutes after complete pulpotomy
- Teeth with root fractures
- Carious furcation involvement
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 |
|---|---|---|
| Vital pulp therapy of immature permanent teethConventional access cavity will be done with a high-speed bur using copious water spray. The coronal pulp amputation will be performed using a sharp spoon excavator. In order to achieve hemostasis sterilized cotton pellet moistened with sterile saline will be placed over the pulp's stumps for 5 minutes, followed by application of the therapeutic agent. The prepared cavities of all molars will be sealed with a layer of glass ionomer over the therapeutic agents and subsequently will be covered with composite resin restoration. | Procedure or surgery | Biodentine will be placed directly in the pulp chamber, Previously trimmed amniotic membrane will be placed directly in the pulp chamber, Putty MTA will be placed directly in the pulp chamber |
Primary outcome
Clinical outcomes
Time frame: Base line, 7 days, 3 months, 6 months , 12 months
Clinical assessment of the treated immature molars in each follow up period as follow: 1. Presence or Absence of pain or sensitivity to percussion. 2. Presence or absence of any evidence of swelling, or sinus tract. 3. Presence or absence of excessive mobility of the treated teeth .
3 secondary outcomes
Radiographic assessment of root length by CBCT
Time frame: Baseline (immediately post-operative ) and 12 months post-operative
Radiographic assessment of diameter of apical foramen by CBCT
Time frame: Baseline (immediately post-operative) and 12 months post-operative)
Radiographic assessment of radiographic root area by CBCT
Time frame: Baseline(immediately post-operative) and at 12 months post-operative
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 13 Jan 2026.
- Background: PubMed 33630330Duncan HF, Nagendrababu V, El-Karim IA, Dummer PMH. Outcome measures to assess the effectiveness of endodontic treatment for pulpitis and apical periodontitis for use in the development of European Society of Endodontology (ESE) S3 level clinical practice guidelines: a protocol. Int Endod J. 2021 May;54(5):646-654. doi: 10.1111/iej.13501. Epub 2021 Mar 15.
- BackgroundDentistry AAoP. Pulp therapy for primary and immature permanent teeth. The Reference Manual of Pediatric Dentistry Chicago, Ill: American Academy of Pediatric Dentistry. 2021;399407.
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 Vital pulp therapy of immature permanent teeth in people with Vital Pulp Therapy in Young Permanent Tooth, run by Al-Azhar 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 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Jan 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?
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?
Clinical outcomes (time frame: Base line, 7 days, 3 months, 6 months , 12 months). 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 NCT07336498, 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 13 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.