Endodontic DiseasePhase 2/3NCT06196515
Anti-bacterial Potential of Nano Calcium Hydroxide as an Intracanal Medication
A Phase 2/3 study testing Calcium hydroxide and nano calcium hydroxide in people with Endodontic Disease and Pulp Disease, Dental, run by British University In Egypt at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the anti-bacterial potential of Nano Calcium Hydroxide as an intracanal medication in primary endodontic treatment of permanent molars. Read more about this study
- Who is it for?
- Ages 21 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease, Pulp Disease, Dental
- What is being tested?
- Calcium hydroxide and nano calcium hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2024to Dec 2025
- Phase
- Phase 2/3
- 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 21 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males and females.
- age range between 21-49.
- patients with no physical disability or psychological problems.
- patients presenting with single permanent molar with signs and/or symptoms of apical periodontitis, and having Periapican index ≥ 2.
Who cannot join
- pregnant women.
- patients with immune-compromised disease.
- patients with complicated systemic diseases.
- patients who took antibiotics within a period of 1 month.
- patients with known sensitivity to the medicaments or pharmaceuticals used in this study.
- Non-restorable teeth including root fractures, and/or advanced periodontal involvement.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
british university in Egypt - dentistry collage
Cairo
Nada T Mohamed, bachelor, +21003577451, pg.nada92140021@bue.edu.eg
About this study
Official title: Evaluation of the Antibacterial Potential of Nano Calcium Hydroxide as an Intracanal Medication: A Randomized Clinical Trial
The aim of the study is to evaluate the anti-bacterial potential of Nano Calcium Hydroxide as an intracanal medication in primary endodontic treatment of permanent molars.
Read the detailed description
This study is conducted to evaluate the bacterial reduction capability of hydrogel loaded with Nano Calcium Hydroxide and paste form of nano and conventional calcium hydroxide as an intracanal medication. The hydrogel will be synthesized in a new rapid in situ form that can turn from liquid into gel when reaching body temperature. The efficacy of bacterial reduction will be compared with Nano Calcium Hydroxide and conventional Calcium Hydroxide in paste form. The evaluation is to be done by quantitative microbiological assessment of samples which are gained from the root canal before and after intracanal medication placement in roots of permanent molars, having PAI score ≥ 2.
- Conditions
- Endodontic Disease, Pulp Disease, Dental
- Being tested
- Calcium hydroxide, nano calcium hydroxide
- Keywords
- intracanal medication
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium hydroxideDrug
placement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week.
nano calcium hydroxideDrug
placement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week.
| Study group | Role | What they receive |
|---|---|---|
| Nano calcium hydroxide in hydrogel form | Experimental | nano calcium hydroxide in hydrogel form is placed in the dry root canals after complete cleaning and shaping procedure.The intracanal medication will be distributed to fill the canals up to the orifice level. Receives: Drug: nano calcium hydroxide |
| Nano calcium hydroxide in paste form | Active comparator | nano calcium hydroxide in paste form is placed in the dry root canals after complete cleaning and shaping procedure. The intracanal medication will be distributed to fill the canals up to the orifice level. Receives: Drug: nano calcium hydroxide |
| Conventional calcium hydroxide in paste form | Active comparator | conventional calcium hydroxide in paste form is placed in the dry root canals after complete cleaning and shaping procedure.The intracanal medication will be distributed to fill the canals up to the orifice level. Receives: Drug: Calcium hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
bacterial count
variation in bacterial count between 'nano calcium in hydrogel form' group compared with the other groups. The evaluation will be done by quantitative microbiological assessment test.
Three microbiological samples will be collected from each patient. Sterile paper points will be used for collecting intracanal content and it will be sealed in Eppendorf tube until the samples reach laboratory center. Tubes will be labelled as following: S1 - S2 - S3 according to the stage of obtaining the sample.
S1: will be obtained after access cavity and patency of canals S2: will be obtained by paper point that match the size of master apical file, after complete cleaning and shaping.
S3: will be obtained on the seventh day from the intracanal placement appointment. paper points will be used after complete removal of the intracanal medication from the root canals.
Measured: on the seventh day from intercanal medication placement appointment
Secondary outcomes (3)
periapical healing
The participants will be recalled after at least 6 months, and radiographic examination of the treated tooth will be performed. Preoperative and recall radiographs of teeth will be each assigned a PAI score by 2 blinded, independent, and calibrated examiners according to Periapical index score (PAI) :
- PAI 1: Normal periapical structure.
- PAI 2: Bone structural changes indicating but not pathognomonic for apical periodontitis.
- PAI 3: Bone structural changes with some mineral loss characteristic for apical periodontitis.
- PAI 4: Well-defined apical radiolucency.
- PAI 5: Radiolucency with radiating expansion of bone structural changes.
Measured: participants will be recalled after 6 months from the obturation for radiographic examination
incidence and intensity of pain
patients will receive visual analogue scale (VAS) to help them assess pain presence and intensity each day for the following three days after intracanal placement appointment (after 24 hours, 48 hours, and 72 hours)
Measured: Pain intensity will be assessed each day for three days following initial treatment
incidence of flare up
Flare up will be presented by 'yes' for developing swelling, and 'no' for not developing swelling. it will be recorded on a chart that will be given to the patients after the initial treatment
Measured: incidence of flare up will be recorded each day after the intracanal medication placment visit until the next visit (after seven days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study startAug 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada, British University In Egypt
- Investigators
- Shehab Eldin M Saber, doctoral, Study director, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196515
- Sponsor's protocol ID
- 23-041
- Status last verified
- Aug 2024
- First submitted
- 10 Dec 2023
- Last updated
- 19 Aug 2024
- 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 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Antibacterial Potential of Nano Calcium Hydroxide as an Intracanal Medication: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06196515
- Acronym / sponsor ID
- 23-041
- Conditions
- Endodontic Disease, Pulp Disease, Dental
- Keywords
- intracanal medication
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Jan 2024 (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 the study is to evaluate the anti-bacterial potential of Nano Calcium Hydroxide as an intracanal medication in primary endodontic treatment of permanent molars.
Detailed description
This study is conducted to evaluate the bacterial reduction capability of hydrogel loaded with Nano Calcium Hydroxide and paste form of nano and conventional calcium hydroxide as an intracanal medication. The hydrogel will be synthesized in a new rapid in situ form that can turn from liquid into gel when reaching body temperature. The efficacy of bacterial reduction will be compared with Nano Calcium Hydroxide and conventional Calcium Hydroxide in paste form. The evaluation is to be done by quantitative microbiological assessment of samples which are gained from the root canal before and after intracanal medication placement in roots of permanent molars, having PAI score ≥ 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nano calcium hydroxide in hydrogel form | Experimental | Drug: nano calcium hydroxidenano calcium hydroxide in hydrogel form is placed in the dry root canals after complete cleaning and shaping procedure.The intracanal medication will be distributed to fill the canals up to the orifice level. |
| Nano calcium hydroxide in paste form | Active comparator | Drug: nano calcium hydroxidenano calcium hydroxide in paste form is placed in the dry root canals after complete cleaning and shaping procedure. The intracanal medication will be distributed to fill the canals up to the orifice level. |
| Conventional calcium hydroxide in paste form | Active comparator | Drug: Calcium hydroxideconventional calcium hydroxide in paste form is placed in the dry root canals after complete cleaning and shaping procedure.The intracanal medication will be distributed to fill the canals up to the orifice level. |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy males and females.
- age range between 21-49.
- patients with no physical disability or psychological problems.
- patients presenting with single permanent molar with signs and/or symptoms of apical periodontitis, and having Periapican index ≥ 2.
Key exclusion criteria (6 listed)
- pregnant women.
- patients with immune-compromised disease.
- patients with complicated systemic diseases.
- patients who took antibiotics within a period of 1 month.
- patients with known sensitivity to the medicaments or pharmaceuticals used in this study.
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 |
|---|---|---|
| Calcium hydroxideplacement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week. | Drug | Conventional calcium hydroxide in paste form |
| nano calcium hydroxideplacement of intracanal medication for the three groups will be done after cleaning and shaping of the root canals and it will be left for one week. | Drug | Nano calcium hydroxide in hydrogel form, Nano calcium hydroxide in paste form |
Primary outcome
bacterial count
Time frame: on the seventh day from intercanal medication placement appointment
variation in bacterial count between 'nano calcium in hydrogel form' group compared with the other groups. The evaluation will be done by quantitative microbiological assessment test. Three microbiological samples will be collected from each patient. Sterile paper points will be used for collecting intracanal content and it will be sealed in Eppendorf tube until the samples reach laboratory center. Tubes will be labelled as following: S1 - S2 - S3 according to the stage of obtaining the sample. S1: will be obtained after access cavity and patency of canals S2: will be obtained by paper point that match the size of master apical file, after complete cleaning and shaping. S3: will be obtained on the seventh day from the intracanal placement appointment. paper points will be used after complete removal of the intracanal medication from the root canals.
3 secondary outcomes
periapical healing
Time frame: participants will be recalled after 6 months from the obturation for radiographic examination
incidence and intensity of pain
Time frame: Pain intensity will be assessed each day for three days following initial treatment
incidence of flare up
Time frame: incidence of flare up will be recorded each day after the intracanal medication placment visit until the next visit (after seven days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- 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.
Shehab Eldin M Saber, doctoral study director
British University In Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Calcium hydroxide and nano calcium hydroxide in people with Endodontic Disease and Pulp Disease, Dental, run by British University In Egypt 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Aug 2024. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada T mohamed, bachelor (+21003577451, pg.nada92140021@bue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bacterial count (time frame: on the seventh day from intercanal medication placement appointment). 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 19 Aug 2024.