Periapical DiseasesNCT07891611
Effect of Combined Root Canal Therapies in Mandibular Molars With Coexistent Mature and Immature Apices on the Healing Outcome
A study testing Bioceramic apical plug and Regenerative endodontic procedure in people with Periapical Diseases, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Recent advancements in dentistry are driven by the development of dental materials and therapies that support tissue regeneration, including the application of bioactive, biocompatible calcium silicate-based materials like mineral trioxide aggregate (MTA), Biodentine, and bioceramic sealers/putties, which facilitated… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Periapical Diseases
- What is being tested?
- Bioceramic apical plug and Regenerative endodontic procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Oct 2026
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 6 to 16 years, of both sexes
- ASA physical status I or II (American Society of Anesthesiologists classification)
- Mandibular first or second permanent molar with non-vital (necrotic) pulp and two separate (non-fused) mesial and distal roots
- Mature mesial root: Cvek stage V root development, apical diameter equal to or less than K-file ISO size 40, Weine type III canal configuration
- Immature distal root: Cvek stage IV root development, apical diameter greater than K-file ISO size 40, Weine type I canal configuration
- Restorable tooth (Class I or II of the classification of teeth with extensive endodontic damage)
Show all 10Show fewer
- Tooth mobility grade 0 or 1 (Miller classification)
- Periodontal probing depth 0 to 3.5 mm (Community Periodontal Index score 0 to 2)
- Periapical radiolucency 0 to 2 mm (Periapical Index score 0 to 2)
- Pre-operative pain score 0 to 5 on the modified Verbal Descriptor Scale
Who cannot join
- ASA physical status III or IV
- Uncooperative patients
- Teeth with fused roots, a single root, or more than two roots
- Teeth in which both the mesial and distal roots are mature, or both are immature
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Combined Root Canal Therapies in Mandibular Molars With Coexistent Mature and Immature Apices on the Healing Outcome (An in Vivo Study)
Recent advancements in dentistry are driven by the development of dental materials and therapies that support tissue regeneration, including the application of bioactive, biocompatible calcium silicate-based materials like mineral trioxide aggregate (MTA), Biodentine, and bioceramic sealers/putties, which facilitated the integration of different treatment protocols. These root canal treatment protocols can be implemented in the same tooth based on the specific stage of root development, such as combining conventional root canal treatment in the root with a closed mature apex, and regeneration or apical plug in the root with an open immature apex, thereby gaining the benefits of each protocol with a minimally invasive, more conservative approach. No research studies have been published evaluating the effect of combined different root canal treatment protocols on the management of molars with coexistent mature and immature apices. This study will evaluate the outcomes of combined root canal therapies in mandibular molars with coexistent mature and immature apices.
- Conditions
- Periapical Diseases
- Being tested
- Bioceramic apical plug, Regenerative endodontic procedure
- Medical subject headings
- Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioceramic apical plugProcedure or surgery
Two-visit treatment of mandibular molars with a mature mesial root and an immature distal root. After chemomechanical preparation (ProTaper Next; 2.5% sodium hypochlorite (NaOCl); final irrigation with 1.5% NaOCl, saline and 17% ethylenediaminetetraacetic acid (EDTA) with sonic activation), a 3 to 4 millimeter (mm) apical plug of bioceramic putty (Bio-C Repair, Angelus) is placed in the immature distal root using the Micro-Apical Placement (MAP) One system. At the second visit, the mature mesial canals are obturated with gutta-percha and a bioceramic sealer (Bio-C Sealer) using warm vertical compaction, and the tooth is restored with composite resin.
Regenerative endodontic procedureProcedure or surgery
Two-visit treatment of mandibular molars with a mature mesial root and an immature distal root. Visit 1: gentle irrigation of the immature distal canal with 1.5% sodium hypochlorite (NaOCl) and saline, then calcium hydroxide intracanal medication (Metapaste) for 2 weeks. Visit 2 (local anesthesia without vasoconstrictor): irrigation with saline and 17% ethylenediaminetetraacetic acid (EDTA), bleeding induced with a precurved size 25 K-file about 2 millimeters (mm) beyond the apex to form an intracanal blood clot, then a coronal barrier of bioceramic putty placed with the Micro-Apical Placement (MAP) One system and covered with glass ionomer. The mature mesial canals are obturated with gutta-percha and a bioceramic sealer using warm vertical compaction, and the tooth is restored with composite resin.
| Study group | Role | What they receive |
|---|---|---|
| Apical plug group | Experimental | Mandibular molars with a mature mesial root and an immature distal root, treated in two visits: a bioceramic apical plug in the immature distal root and conventional root canal treatment in the mature mesial root. Receives: Procedure: Bioceramic apical plug |
| Regeneration group | Experimental | Mandibular molars with a mature mesial root and an immature distal root, treated in two visits: a regenerative endodontic procedure in the immature distal root and conventional root canal treatment in the mature mesial root. Receives: Procedure: Regenerative endodontic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periapical healing assessed by the Periapical Index (PAI)
Periapical status of the treated tooth scored with the Periapical Index (PAI) on digital periapical radiographs at 3, 6 and 12 months, and on cone-beam computed tomography (CBCT) at 12 months. Lower scores indicate healthier periapical status. Reported as the number (%) of teeth in each PAI score category.
Measured: Baseline, 3, 6 and 12 months after treatment
Secondary outcomes (7)
Tenderness to percussion
Number (%) of teeth with tenderness to percussion. Each tooth was percussed three times on the cusps with the shaft of a straight probe and scored as negative (no pain or discomfort) or positive (pain or discomfort compared with adjacent and contralateral teeth).
Measured: 3, 6 and 12 months after treatment
Tenderness to palpation
Number (%) of teeth with tenderness to palpation, assessed by firm digital pressure over the buccal and lingual cortical plates at the root apices and scored as negative (no tenderness) or positive (tenderness or pain).
Measured: 3, 6 and 12 months after treatment
Presence of a sinus tract
Number (%) of teeth with a sinus tract present on clinical examination.
Measured: 3 and 12 months after treatment
Increased tooth mobility
Number (%) of teeth with increased tooth mobility, graded with Miller's classification (grade 0, physiological; grade 1, slight; grade 2, moderate; grade 3, severe).
Measured: 12 months after treatment
Postoperative pain intensity
Pain intensity self-reported by patients on a modified Verbal Descriptor Scale (VDS) from 0 (no pain) to 10 (worst pain), using an Arabic-language form.
Measured: 24, 48, 72, 96 and 120 hours after treatment
Postoperative swelling
Swelling self-reported by patients on a four-point scale: 0 = none, 1 = mild intraoral swelling, 2 = moderate localized facial swelling, 3 = severe diffuse facial swelling.
Measured: 24, 48, 72, 96 and 120 hours after treatment
Pattern of radiographic response of the immature distal root
Radiographic response classified according to Chen et al.: type I, continued root maturation with canal wall thickening; type II, apex becomes blunt and closed without further root development; type III, continued root development with an open apex; type IV, severe canal calcification; type V, hard-tissue barrier formed in the canal. Reported as the number (%) of teeth of each type.
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Oct 2024
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical DiseasesStudies 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy Mahmoud Sayed Barakat, Al-Azhar University
- Investigators
- Mohamed Magdy Barakat, BDS, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891611
- Sponsor's protocol ID
- 24/9/2024
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Root Canal Therapies in Mandibular Molars With Coexistent Mature and Immature Apices on the Healing Outcome (An in Vivo Study)
- ClinicalTrials.gov ID
- NCT07891611
- Acronym / sponsor ID
- 24/9/2024
- Conditions
- Periapical Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 23 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.
Recent advancements in dentistry are driven by the development of dental materials and therapies that support tissue regeneration, including the application of bioactive, biocompatible calcium silicate-based materials like mineral trioxide aggregate (MTA), Biodentine, and bioceramic sealers/putties, which facilitated the integration of different treatment protocols. These root canal treatment protocols can be implemented in the same tooth based on the specific stage of root development, such as combining conventional root canal treatment in the root with a closed mature apex, and regeneration or apical plug in the root with an open immature apex, thereby gaining the benefits of each protocol with a minimally invasive, more conservative approach. No research studies have been published evaluating the effect of combined different root canal treatment protocols on the management of molars with coexistent mature and immature apices. This study will evaluate the outcomes of combined root canal therapies in mandibular molars with coexistent mature and immature apices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apical plug group | Experimental | Procedure: Bioceramic apical plugMandibular molars with a mature mesial root and an immature distal root, treated in two visits: a bioceramic apical plug in the immature distal root and conventional root canal treatment in the mature mesial root. |
| Regeneration group | Experimental | Procedure: Regenerative endodontic procedureMandibular molars with a mature mesial root and an immature distal root, treated in two visits: a regenerative endodontic procedure in the immature distal root and conventional root canal treatment in the mature mesial root. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Patients aged 6 to 16 years, of both sexes
- ASA physical status I or II (American Society of Anesthesiologists classification)
- Mandibular first or second permanent molar with non-vital (necrotic) pulp and two separate (non-fused) mesial and distal roots
- Mature mesial root: Cvek stage V root development, apical diameter equal to or less than K-file ISO size 40, Weine type III canal configuration
- Immature distal root: Cvek stage IV root development, apical diameter greater than K-file ISO size 40, Weine type I canal configuration
Key exclusion criteria (4 listed)
- ASA physical status III or IV
- Uncooperative patients
- Teeth with fused roots, a single root, or more than two roots
- Teeth in which both the mesial and distal roots are mature, or both are immature
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 |
|---|---|---|
| Bioceramic apical plugTwo-visit treatment of mandibular molars with a mature mesial root and an immature distal root. After chemomechanical preparation (ProTaper Next; 2.5% sodium hypochlorite (NaOCl); final irrigation with 1.5% NaOCl, saline and 17% ethylenediaminetetraacetic acid (EDTA) with sonic activation), a 3 to 4 millimeter (mm) apical plug of bioceramic putty (Bio-C Repair, Angelus) is placed in the immature distal root using the Micro-Apical Placement (MAP) One system. At the second visit, the mature mesial canals are obturated with gutta-percha and a bioceramic sealer (Bio-C Sealer) using warm vertical compaction, and the tooth is restored with composite resin. | Procedure or surgery | Apical plug group |
| Regenerative endodontic procedureTwo-visit treatment of mandibular molars with a mature mesial root and an immature distal root. Visit 1: gentle irrigation of the immature distal canal with 1.5% sodium hypochlorite (NaOCl) and saline, then calcium hydroxide intracanal medication (Metapaste) for 2 weeks. Visit 2 (local anesthesia without vasoconstrictor): irrigation with saline and 17% ethylenediaminetetraacetic acid (EDTA), bleeding induced with a precurved size 25 K-file about 2 millimeters (mm) beyond the apex to form an intracanal blood clot, then a coronal barrier of bioceramic putty placed with the Micro-Apical Placement (MAP) One system and covered with glass ionomer. The mature mesial canals are obturated with gutta-percha and a bioceramic sealer using warm vertical compaction, and the tooth is restored with composite resin. | Procedure or surgery | Regeneration group |
Primary outcome
Periapical healing assessed by the Periapical Index (PAI)
Time frame: Baseline, 3, 6 and 12 months after treatment
Periapical status of the treated tooth scored with the Periapical Index (PAI) on digital periapical radiographs at 3, 6 and 12 months, and on cone-beam computed tomography (CBCT) at 12 months. Lower scores indicate healthier periapical status. Reported as the number (%) of teeth in each PAI score category.
7 secondary outcomes
Tenderness to percussion
Time frame: 3, 6 and 12 months after treatment
Tenderness to palpation
Time frame: 3, 6 and 12 months after treatment
Presence of a sinus tract
Time frame: 3 and 12 months after treatment
Increased tooth mobility
Time frame: 12 months after treatment
Postoperative pain intensity
Time frame: 24, 48, 72, 96 and 120 hours after treatment
Postoperative swelling
Time frame: 24, 48, 72, 96 and 120 hours after treatment
Pattern of radiographic response of the immature distal root
Time frame: 12 months after treatment
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 23 Oct 2026.
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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.
Mohamed Magdy Barakat, BDS principal investigator
Al-Azhar 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 Bioceramic apical plug and Regenerative endodontic procedure in people with Periapical Diseases, 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 10 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: finished, as of the sponsor's last update on 23 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?
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?
Periapical healing assessed by the Periapical Index (PAI) (time frame: Baseline, 3, 6 and 12 months after treatment). 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 23 Oct 2026.