Pain ManagementEarly Phase 1HCPHNCT07821866
Comparing the Effectiveness of Hyalone and Calcium Hydroxide in Reducing Post-operative Pain and Promoting Periapical Healing.
A Early Phase 1 study testing Hyalone and Calcium Hydroxide (Ca(OH)2) Intracanal Medication in people with Pain Management, run by Future University in Egypt at 1 site in Egypt.
Trial summary
This protocol presents a randomized clinical trial comparing Hyalone (hyaluronic acid) with calcium hydroxide as intracanal medicaments in mandibular first molars with necrotic pulp and symptomatic apical periodontitis. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- Hyalone and Calcium Hydroxide (Ca(OH)2) Intracanal Medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2026to 1 Apr 2027
- Phase
- Early Phase 1
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).
- Age range is between 20 to 40 years.
- Patients have restorable permanent mandibular first molars (mesial root type III and distal canal type III) that were diagnosed necrotic with symptomatic apical periodontitis with small to moderate periapical lesion less that 5 mm according to CBCT-PAI in highest diameter at any axis in CBCT).
- Positive patient's acceptance for participating in the study.
- Patients able to sign informed consent
Who cannot join
- • Medically compromised patients.
- Pregnant or lactating females.
- Psychologically disturbed patients.
- Patients with a history of allergy to any medication used in the study were excluded.
- Teeth that have:
- Periodontally affected with grade 2 or 3 mobility.
Show all 9Show fewer
- Not restorable teeth.
- Abnormal anatomy and calcified canals.
- Previous root canal treatment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental Medicine, Future University in Egypt
Cairo
About this study
Official title: Comparative Evaluation of Hyalone and Calcium Hydroxide on Post-Operative Pain and Periapical Healing in Mandibular Molars Teeth With Necrotic Pulp and Symptomatic Apical Periodontitis .
This protocol presents a randomized clinical trial comparing Hyalone (hyaluronic acid) with calcium hydroxide as intracanal medicaments in mandibular first molars with necrotic pulp and symptomatic apical periodontitis. The study aims to determine whether Hyalone provides better postoperative pain reduction and periapical healing than calcium hydroxide.
- Conditions
- Pain Management
- Being tested
- Hyalone, Calcium Hydroxide (Ca(OH)2) Intracanal Medication
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyaloneDrug
Also called Intervention 1
Hyalone will be used as an intracanal medicament during two-appointment root canal treatment. The medicament will be placed in the root canals after biomechanical preparation and irrigation and maintained for 7 days before final obturation.
Calcium Hydroxide (Ca(OH)2) Intracanal MedicationDrug
Calcium hydroxide will be used as an intracanal medicament during two-appointment root canal treatment. The medicament will be placed in the root canals after biomechanical preparation and maintained for 7 days before final obturation.
| Study group | Role | What they receive |
|---|---|---|
| calcium hydroxide intracanal medication | Active comparator | Not described Receives: Drug: Calcium Hydroxide (Ca(OH)2) Intracanal Medication |
| Hyalone Intracanal Medication | Experimental | Not described Receives: Drug: Hyalone |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain
Postoperative pain will be assessed using the Modified Visual Analogue Scale (mVAS), an 11-point numeric scale with a minimum score of 0 and a maximum score of 10, accompanied by corresponding facial-expression icons at each level. Higher scores indicate worse pain: a score of 0 represents "no pain" and a score of 10 represents "the worst pain imaginable." Scores will be categorized as no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10). Each participant will record pain intensity in a standardized pain diary at each designated time point following intracanal medicament placement. Mean pain scores will be compared between the calcium hydroxide (control) and Hyalone (intervention) groups at each time point.
Measured: 6 hours,12hours,24 hours, 72 hours & 1week
Secondary outcomes (2)
periapical healing
Periapical healing will be assessed radiographically using cone-beam computed tomography (CBCT), evaluated in the axial, sagittal, and coronal planes with the mesial and distal roots scored separately. Healing status will be scored using the Cone-Beam Computed Tomography Periapical Index (CBCT-PAI), and follow-up scores will be compared with the baseline preoperative CBCT to determine change in periapical lesion size. Based on combined clinical and radiographic findings, each treated tooth will be classified as healed (no clinical signs or symptoms, with complete radiographic resolution of the periapical lesion or a CBCT-PAI score of 1 or 2), healing (no clinical signs or symptoms, with a reduction in lesion size and CBCT-PAI score compared with baseline), or diseased (persistent or new clinical signs or symptoms, or no reduction/an increase in lesion size or CBCT-PAI score). For statistical analysis, outcomes will be dichotomized: teeth classified as healed or healing will be conside
Measured: 6months & 12 months
preapical healing
Periapical healing will be assessed radiographically using cone-beam computed tomography (CBCT), evaluated in the axial, sagittal, and coronal planes with the mesial and distal roots scored separately. Healing status will be scored using the Cone-Beam Computed Tomography Periapical Index (CBCT-PAI), and follow-up scores will be compared with the baseline preoperative CBCT to determine change in periapical lesion size. Based on combined clinical and radiographic findings, each treated tooth will be classified as healed (no clinical signs or symptoms, with complete radiographic resolution of the periapical lesion or a CBCT-PAI score of 1 or 2), healing (no clinical signs or symptoms, with a reduction in lesion size and CBCT-PAI score compared with baseline), or diseased (persistent or new clinical signs or symptoms, or no reduction/an increase in lesion size or CBCT-PAI score). For statistical analysis, outcomes will be dichotomized: teeth classified as healed or healing will be conside
Measured: 6 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start5 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Tarek Idrees Ewis, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821866
- Sponsor's protocol ID
- FUE.REC18/1-2026
- Acronym
- HCPH
- Status last verified
- Jan 2026
- First submitted
- 6 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision on data sharing has not yet been made. If shared in the future, de-identified individual participant data (pain scores and periapical healing indices) may be made available upon reasonable request."
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Hyalone and Calcium Hydroxide on Post-Operative Pain and Periapical Healing in Mandibular Molars Teeth With Necrotic Pulp and Symptomatic Apical Periodontitis .
- ClinicalTrials.gov ID
- NCT07821866
- Acronym / sponsor ID
- HCPH / FUE.REC18/1-2026
- Conditions
- Pain Management
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 5 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 16 Sep 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 protocol presents a randomized clinical trial comparing Hyalone (hyaluronic acid) with calcium hydroxide as intracanal medicaments in mandibular first molars with necrotic pulp and symptomatic apical periodontitis. The study aims to determine whether Hyalone provides better postoperative pain reduction and periapical healing than calcium hydroxide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcium hydroxide intracanal medication | Active comparator | Drug: Calcium Hydroxide (Ca(OH)2) Intracanal Medication |
| Hyalone Intracanal Medication | Experimental | Drug: Hyalone |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).
Key exclusion criteria (9 listed)
- • Medically compromised patients.
- Periodontally affected with grade 2 or 3 mobility.
- Not restorable teeth.
- Abnormal anatomy and calcified canals.
- Previous root canal treatment.
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 |
|---|---|---|
| HyaloneAlso: Intervention 1Hyalone will be used as an intracanal medicament during two-appointment root canal treatment. The medicament will be placed in the root canals after biomechanical preparation and irrigation and maintained for 7 days before final obturation. | Drug | Hyalone Intracanal Medication |
| Calcium Hydroxide (Ca(OH)2) Intracanal MedicationCalcium hydroxide will be used as an intracanal medicament during two-appointment root canal treatment. The medicament will be placed in the root canals after biomechanical preparation and maintained for 7 days before final obturation. | Drug | calcium hydroxide intracanal medication |
Primary outcome
post-operative pain
Time frame: 6 hours,12hours,24 hours, 72 hours & 1week
Postoperative pain will be assessed using the Modified Visual Analogue Scale (mVAS), an 11-point numeric scale with a minimum score of 0 and a maximum score of 10, accompanied by corresponding facial-expression icons at each level. Higher scores indicate worse pain: a score of 0 represents "no pain" and a score of 10 represents "the worst pain imaginable." Scores will be categorized as no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10). Each participant will record pain intensity in a standardized pain diary at each designated time point following intracanal medicament placement. Mean pain scores will be compared between the calcium hydroxide (control) and Hyalone (intervention) groups at each time point.
2 secondary outcomes
periapical healing
Time frame: 6months & 12 months
preapical healing
Time frame: 6 month and 12 month
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 16 Sep 2026.
- Individual participant dataSharing planned: Undecided. A decision on data sharing has not yet been made. If shared in the future, de-identified individual participant data (pain scores and periapical healing indices) may be made available upon reasonable request."
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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 Early Phase 1 study testing Hyalone and Calcium Hydroxide (Ca(OH)2) Intracanal Medication in people with Pain Management, run by Future 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 5 inclusion and 9 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 16 Sep 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
post-operative pain (time frame: 6 hours,12hours,24 hours, 72 hours & 1week). 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 16 Sep 2026.