Endodontic-Periodontal LesionsNCT07858396
The Effect of Different Intra-canal Medications on Healing of Endo-perio Cases.
A study testing Bio-ceramic, Calcium Hydroxide (CH) and Chlorhexidine in people with Endodontic-Periodontal Lesions and Apical Periodontitis, run by Ain Shams University at 1 site in Egypt.
Trial summary
Assessment of different intra-canal medications in endo-perio lesion regarding their healing potentiality and their effect on local cytokine levels. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endodontic-Periodontal Lesions, Apical Periodontitis
- What is being tested?
- Bio-ceramic, Calcium Hydroxide (CH) and Chlorhexidine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Aug 2024to 23 Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Medically healthy patients.
- Deep probing depth.
- Non-vital pulp, confirmed by pulp sensibility test.
- Radiographic periapical radiolucency.
- Radiographic marginal bone destruction with apical communication.
Who cannot join
- Systemic health conditions or medications known to interfere with healing or alter cytokine levels.
- Known allergy to medications used in the study.
- Pregnancy or lactation.
- Teeth with grade III mobility.
- Root resorption.
- Non-restorable teeth.
- Previously endodontically treated teeth.
- Inability or refusal to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healing Potentiality of Different Intra-Canal Medications in Endo-Perio Lesion (In Vivo Study)
Assessment of different intra-canal medications in endo-perio lesion regarding their healing potentiality and their effect on local cytokine levels.
Read the detailed description
Selected cases of endo-perio lesion will be divided into three groups according to the type of intra-canal medication that will be used. Three peri-apical fluid samples will be collected from each participant: the first will be collected after root canal preparation, the second will be collected two weeks after the intra-canal medication placement, and the last will be collected two weeks after periodontal treatment. Local cytokine will be quantified using enzyme-linked immunosorbent assay (ELISA). Periapical healing will be evaluated using CBCT and the pocket depth reduction will be assessed after one year of follow-up.
- Being tested
- Bio-ceramic, Calcium Hydroxide (CH), Chlorhexidine
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-ceramicDevice
Bio-ceramic ICM was placed for 2 weeks after root canal treatment
Calcium Hydroxide (CH)Device
Calcium hydroxide ICM was placed for 2 weeks after root canal treatment
ChlorhexidineDevice
Chlorhexidine ICM was placed for 2 weeks after root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| Bio-ceramic | Experimental | RCT was done then bio-ceramic ICM was placed for 2 weeks then periodontal treatment was performed Receives: Device: Bio-ceramic |
| Calcium hydroxide | Active comparator | RCT was done then calcium hydroxide ICM was placed for 2 weeks then periodontal treatment was performed Receives: Device: Calcium Hydroxide (CH) |
| Chlorhexidine | Experimental | RCT was done then chlorhexidine ICM was placed for 2 weeks then periodontal treatment was performed Receives: Device: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing
Volume change of periapical lesion in CBCT
Measured: 1 year
Secondary outcomes (1)
Local cytokines level (TNF-a in periapical fluid)
Measure TNF-a concentration by ELISA
Measured: base line - 2 weeks after ICM - 2 weeks after periodontal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start28 Aug 2024
- Primary completion23 Apr 2026
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic-Periodontal LesionsStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mamdouh, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858396
- Sponsor's protocol ID
- 333
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Potentiality of Different Intra-Canal Medications in Endo-Perio Lesion (In Vivo Study)
- ClinicalTrials.gov ID
- NCT07858396
- Acronym / sponsor ID
- 333
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 5 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.
Assessment of different intra-canal medications in endo-perio lesion regarding their healing potentiality and their effect on local cytokine levels.
Detailed description
Selected cases of endo-perio lesion will be divided into three groups according to the type of intra-canal medication that will be used. Three peri-apical fluid samples will be collected from each participant: the first will be collected after root canal preparation, the second will be collected two weeks after the intra-canal medication placement, and the last will be collected two weeks after periodontal treatment. Local cytokine will be quantified using enzyme-linked immunosorbent assay (ELISA). Periapical healing will be evaluated using CBCT and the pocket depth reduction will be assessed after one year of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bio-ceramic | Experimental | Device: Bio-ceramicRCT was done then bio-ceramic ICM was placed for 2 weeks then periodontal treatment was performed |
| Calcium hydroxide | Active comparator | Device: Calcium Hydroxide (CH)RCT was done then calcium hydroxide ICM was placed for 2 weeks then periodontal treatment was performed |
| Chlorhexidine | Experimental | Device: ChlorhexidineRCT was done then chlorhexidine ICM was placed for 2 weeks then periodontal treatment was performed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Medically healthy patients.
- Deep probing depth.
- Non-vital pulp, confirmed by pulp sensibility test.
- Radiographic periapical radiolucency.
- Radiographic marginal bone destruction with apical communication.
Key exclusion criteria (8 listed)
- Systemic health conditions or medications known to interfere with healing or alter cytokine levels.
- Known allergy to medications used in the study.
- Pregnancy or lactation.
- Teeth with grade III mobility.
- 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 |
|---|---|---|
| Bio-ceramicBio-ceramic ICM was placed for 2 weeks after root canal treatment | Device | Bio-ceramic |
| Calcium Hydroxide (CH)Calcium hydroxide ICM was placed for 2 weeks after root canal treatment | Device | Calcium hydroxide |
| ChlorhexidineChlorhexidine ICM was placed for 2 weeks after root canal treatment | Device | Chlorhexidine |
Primary outcome
healing
Time frame: 1 year
Volume change of periapical lesion in CBCT
1 secondary outcome
Local cytokines level (TNF-a in periapical fluid)
Time frame: base line - 2 weeks after ICM - 2 weeks after periodontal 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 7 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 Bio-ceramic, Calcium Hydroxide (CH) and Chlorhexidine in people with Endodontic-Periodontal Lesions and Apical Periodontitis, run by Ain Shams 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 8 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 7 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?
healing (time frame: 1 year). 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 7 Oct 2026.