Bacterial Load ReductionPhase 2HYACAL-ENDONCT07775456
Evaluation of Postoperative Pain and Bacterial Load After Hyalone or Calcium Hydroxide Medication in Mandibular First Molars
A Phase 2 study testing Hyalone and Calcium Hydroxide (Ca(OH)2) Intracanal Medication in people with Bacterial Load Reduction and Postoperative Pain, run by Future University in Egypt at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial aims to evaluate the effect of Hyalone hydrogel compared with calcium hydroxide as an intracanal medicament on postoperative pain and bacterial load reduction 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
- Bacterial Load Reduction, Postoperative Pain
- What is being tested?
- Hyalone and Calcium Hydroxide (Ca(OH)2) Intracanal Medication
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 1 Mar 2027
- Phase
- Phase 2
- 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).
- Positive patient acceptance for participating in the study. Patients able to sign informed consent. Age range is between 20 to 40 years. No sex predilection. Mandibular first molars teeth with necrotic pulp and symptomatic apical periodontitis.
- Type l distal root canal (Vertucci classification). Teeth Sensitive to percussion. Teeth with Periapical radiographic appearance showing slight widening in lamina dura.
- Restorable teeth.
- B- Exclusion criteria:
- 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.
Show all 10Show fewer
- If anti-inflammatory analgesics or antibiotics have been administrated by patient during the past 12 hours preoperatively.
- Patients with swelling or acute peri-apical abscess or fistulous tract.
- Teeth that have:
- Wide or open apex. Vital pulp tissues. affected with grade 2 or 3 mobility. Not restorable teeth.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Postoperative Pain and Bacterial Load Reduction of Hyalone VS Calcium Hydroxide as Intracanal Medication in Mandibular First Molar Teeth With Necrotic Pulp and Symptomatic Apical Periodontitis "Randomized Controlled Trial"
This randomized controlled clinical trial aims to evaluate the effect of Hyalone hydrogel compared with calcium hydroxide as an intracanal medicament on postoperative pain and bacterial load reduction in mandibular first molars with necrotic pulp and symptomatic apical periodontitis. The rationale for the study is based on the important role of intracanal medicaments in reducing residual microorganisms between treatment appointments. Calcium hydroxide is widely used because of its antimicrobial activity and alkaline pH; however, it has limitations related to its distribution, adherence to canal walls, antimicrobial spectrum, and effectiveness against microorganisms in complex root canal anatomy. Hyaluronic acid hydrogel has demonstrated potential benefits in dentistry, including supporting tissue healing and reducing inflammation and pain, and may therefore represent a promising alternative intracanal medicament.
The study will include 28 patients, equally divided into two groups of 14 participants. Patients will be recruited from the Endodontic Department outpatient clinic at the Faculty of Oral and Dental Medicine, Future University in Egypt. Eligible participants will be medically healthy patients aged 20-40 years, with mandibular first molars diagnosed with necrotic pulp and symptomatic apical periodontitis. Teeth should have closed apices, be restorable, be sensitive to percussion, and demonstrate slight widening of the lamina dura radiographically. Patients with systemic diseases, pregnancy or lactation, allergies to study medications, recent use of antibiotics or analgesics, swelling or acute apical abscess, open apices, vital pulp, periodontal mobility, previous root canal treatment, or abnormal/calcified canal anatomy will be excluded.
Read more
All participants will receive standardized endodontic treatment over two visits. During the first visit, medical and dental histories, clinical examination, radiographic examination, and preoperative pain assessment using the Numerical Rating Scale (NRS) will be performed. Following local anesthesia, caries removal, access cavity preparation, and rubber dam isolation, working length will be determined using an electronic apex locator and confirmed radiographically. The initial bacteriological sample (S1) will then be collected using sterile #15 paper points placed in the canal for one minute each. The samples will be processed microbiologically, and bacterial counts will be expressed as colony-forming units per milliliter (CFU/mL).
Cleaning and shaping will then be performed using a crown-down rotary instrumentation technique, with sterile saline irrigation between instruments. Following completion of instrumentation, a second bacteriological sample (S2) will be obtained to determine the reduction in bacterial load resulting from chemomechanical preparation. Patients will subsequently receive either Hyalone or calcium hydroxide, according to their randomized allocation. The medicament will be placed under aseptic conditions, and the access cavity will be temporarily restored using glass ionomer.
At the second visit after 7 days, the temporary restoration and intracanal medicament will be removed. The canals will be irrigated with sterile saline and a third bacteriological sample (S3) will be collected. This sample will allow assessment of the additional bacterial reduction associated with the intracanal medicament. Following sampling, the canals will be irrigated with 2.5% sodium hypochlorite and obturated using the cold lateral condensation technique with gutta-percha and resin sealer. The teeth will then receive a final composite restoration.
The primary outcome of the study is postoperative pain. Pain will be recorded using an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as could be). Patients will record their pain preoperatively and at 6, 12, 24, 48, and 72 hours and one week following treatment. Pain scores will also be categorized as none, mild, moderate, or severe.
The secondary outcome is the antimicrobial effect of the two intracanal medicaments. Bacterial samples obtained at S1, S2, and S3 will be analyzed using the serial dilution technique, with bacterial counts expressed as CFU/mL. Samples will be processed under aerobic and anaerobic conditions to assess the cultivable bacterial population. The changes in bacterial load before instrumentation, after chemomechanical preparation, and after intracanal medication will then be compared.
The sample size was calculated based on a previous study, with a minimum required sample of 11 participants per group. The number was increased to 14 participants
- Conditions
- Bacterial Load Reduction, Postoperative Pain
- Being tested
- Hyalone, Calcium Hydroxide (Ca(OH)2) Intracanal Medication
- Keywords
- HYACAL, calcium hydroxide, postoperative pain, bacterial load reduction
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyaloneDrug
Group I (Hyalone® gel): Hyaluronic acid gel (Hyalone®) was delivered using a sterile 3-mL disposable syringe fitted with a flexible 30-gauge endodontic NaviTip.
Calcium Hydroxide (Ca(OH)2) Intracanal MedicationDrug
Group II (MetaPaste®): Calcium hydroxide paste (MetaPaste®, Meta Biomed, Chungcheongbuk-do, Republic of Korea) was delivered using the manufacturer's preloaded syringe fitted with a disposable intracanal delivery tip.
| Study group | Role | What they receive |
|---|---|---|
| calcium hydroxide | Experimental | Group II (Calcium hydroxide metapaste):n/14 patients Root canals were medicated with calcium hydroxide paste. Receives: Drug: Calcium Hydroxide (Ca(OH)2) Intracanal Medication |
| hyalone | Experimental | Group I (Hyalone group):n/14 patients Root canals were medicated with Hyalone gel(hyaluronic acid sodium salt 1.5%-60mg/4ml). Receives: Drug: Hyalone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial load reductiion
Antimicrobial effect will be measured by counting the number of bacteria present in the root canal using serial dilution technique.
Samples will be acquired by placing #15 sterile paper points in the canal for 1 minute each.
Some of the paper points will be placed in broth to isolate the facultative anaerobes, while the others will be placed in a suitable transport medium to isolate the obligate anaerobes. The tubes will then be transported to the laboratory .
Each swab will be cultivated onto separate agar plates and incubated at 37 C for 24 hours. One plate will be incubated aerobically and the other will be incubated anaerobically in order to isolate the obligate anaerobes. The number of bacterial colonies on each plate will then be counted using serial dilution technique to find the number of colony forming units per ml (CFU/ml)
Measured: 1 week
postoperative pain measurement
Postoperative pain will be measured using numerical rate scale (NRS) after 6, 12, 24, 48, 72 and 1 week from the end of endodontic treatment.
The NRS consists of 11 point scale from 0 to 10 anchored by two extremes "No pain" and "pain as bad as could be", patient will be asked to choose the mark that represent their level of pain. Pain level will be assigned to one of 4 categorical scores:
None (0); Mild (1-3); Moderate (4-6); Severe (7-10).
Measured: 1 week
Secondary outcomes (1)
bacterial load reduction
Antimicrobial effect will be measured by counting the number of bacteria present in the root canal using serial dilution technique.
Samples will be acquired by placing #15 sterile paper points in the canal for 1 minute each.
Some of the paper points will be placed in broth to isolate the facultative anaerobes, while the others will be placed in a suitable transport medium to isolate the obligate anaerobes. The tubes will then be transported to the laboratory .
Each swab will be cultivated onto separate agar plates and incubated at 37 C for 24 hours. One plate will be incubated aerobically and the other will be incubated anaerobically in order to isolate the obligate anaerobes. The number of bacterial colonies on each plate will then be counted using serial dilution technique to find the number of colony forming units per ml (CFU/ml).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Jun 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Load ReductionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher Rasmy, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775456
- Sponsor's protocol ID
- FUE.REC(15)/1-2026
- Acronym
- HYACAL-ENDO
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Pain and Bacterial Load Reduction of Hyalone VS Calcium Hydroxide as Intracanal Medication in Mandibular First Molar Teeth With Necrotic Pulp and Symptomatic Apical Periodontitis "Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT07775456
- Acronym / sponsor ID
- HYACAL-ENDO / FUE.REC(15)/1-2026
- Conditions
- Bacterial Load Reduction, Postoperative Pain
- Keywords
- HYACAL, calcium hydroxide, postoperative pain, bacterial load reduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 20 Aug 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 randomized controlled clinical trial aims to evaluate the effect of Hyalone hydrogel compared with calcium hydroxide as an intracanal medicament on postoperative pain and bacterial load reduction in mandibular first molars with necrotic pulp and symptomatic apical periodontitis. The rationale for the study is based on the important role of intracanal medicaments in reducing residual microorganisms between treatment appointments. Calcium hydroxide is widely used because of its antimicrobial activity and alkaline pH; however, it has limitations related to its distribution, adherence to canal walls, antimicrobial spectrum, and effectiveness against microorganisms in complex root canal anatomy. Hyaluronic acid hydrogel has demonstrated potential benefits in dentistry, including supporting tissue healing and reducing inflammation and pain, and may therefore represent a promising alternative intracanal medicament.
The study will include 28 patients, equally divided into two groups of 14 participants. Patients will be recruited from the Endodontic Department outpatient clinic at the Faculty of Oral and Dental Medicine, Future University in Egypt. Eligible participants will be medically healthy patients aged 20-40 years, with mandibular first molars diagnosed with necrotic pulp and symptomatic apical periodontitis. Teeth should have closed apices, be restorable, be sensitive to percussion, and demonstrate slight widening of the lamina dura radiographically. Patients with systemic diseases, pregnancy or lactation, allergies to study medications, recent use of antibiotics or analgesics, swelling or acute apical abscess, open apices, vital pulp, periodontal mobility, previous root canal treatment, or abnormal/calcified canal anatomy will be excluded.
All participants will receive standardized endodontic treatment over two visits. During the first visit, medical and dental histories, clinical examination, radiographic examination, and preoperative pain assessment using the Numerical Rating Scale (NRS) will be performed. Following local anesthesia, caries removal, access cavity preparation, and rubber dam isolation, working length will be determined using an electronic apex locator and confirmed radiographically. The initial bacteriological sample (S1) will then be collected using sterile #15 paper points placed in the canal for one minute each. The samples will be processed microbiologically, and bacterial counts will be expressed as colony-forming units per milliliter (CFU/mL).
Cleaning and shaping will then be performed using a crown-down rotary instrumentation technique, with sterile saline irrigation between instruments. Following completion of instrumentation, a second bacteriological sample (S2) will be obtained to determine the reduction in bacterial load resulting from chemomechanical preparation. Patients will subsequently receive either Hyalone or calcium hydroxide, according to their randomized allocation. The medicament will be placed under aseptic conditions, and the access cavity will be temporarily restored using glass ionomer.
At the second visit after 7 days, the temporary restoration and intracanal medicament will be removed. The canals will be irrigated with sterile saline and a third bacteriological sample (S3) will be collected. This sample will allow assessment of the additional bacterial reduction associated with the intracanal medicament. Following sampling, the canals will be irrigated with 2.5% sodium hypochlorite and obturated using the cold lateral condensation technique with gutta-percha and resin sealer. The teeth will then receive a final composite restoration.
The primary outcome of the study is postoperative pain. Pain will be recorded using an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as could be). Patients will record their pain preoperatively and at 6, 12, 24, 48, and 72 hours and one week following treatment. Pain scores will also be categorized as none, mild, moderate, or severe.
The secondary outcome is the antimicrobial effect of the two intracanal medicaments. Bacterial samples obtained at S1, S2, and S3 will be analyzed using the serial dilution technique, with bacterial counts expressed as CFU/mL. Samples will be processed under aerobic and anaerobic conditions to assess the cultivable bacterial population. The changes in bacterial load before instrumentation, after chemomechanical preparation, and after intracanal medication will then be compared.
The sample size was calculated based on a previous study, with a minimum required sample of 11 participants per group. The number was increased to 14 participants
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 | Experimental | Drug: Calcium Hydroxide (Ca(OH)2) Intracanal MedicationGroup II (Calcium hydroxide metapaste):n/14 patients Root canals were medicated with calcium hydroxide paste. |
| hyalone | Experimental | Drug: HyaloneGroup I (Hyalone group):n/14 patients Root canals were medicated with Hyalone gel(hyaluronic acid sodium salt 1.5%-60mg/4ml). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).
- Positive patient acceptance for participating in the study. Patients able to sign informed consent. Age range is between 20 to 40 years. No sex predilection. Mandibular first molars teeth with necrotic pulp and symptomatic apical periodontitis.
- Type l distal root canal (Vertucci classification). Teeth Sensitive to percussion. Teeth with Periapical radiographic appearance showing slight widening in lamina dura.
- Restorable teeth.
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| HyaloneGroup I (Hyalone® gel): Hyaluronic acid gel (Hyalone®) was delivered using a sterile 3-mL disposable syringe fitted with a flexible 30-gauge endodontic NaviTip. | Drug | hyalone |
| Calcium Hydroxide (Ca(OH)2) Intracanal MedicationGroup II (MetaPaste®): Calcium hydroxide paste (MetaPaste®, Meta Biomed, Chungcheongbuk-do, Republic of Korea) was delivered using the manufacturer's preloaded syringe fitted with a disposable intracanal delivery tip. | Drug | calcium hydroxide |
Primary outcome
Bacterial load reductiion
Time frame: 1 week
Antimicrobial effect will be measured by counting the number of bacteria present in the root canal using serial dilution technique. Samples will be acquired by placing #15 sterile paper points in the canal for 1 minute each. Some of the paper points will be placed in broth to isolate the facultative anaerobes, while the others will be placed in a suitable transport medium to isolate the obligate anaerobes. The tubes will then be transported to the laboratory . Each swab will be cultivated onto separate agar plates and incubated at 37 C for 24 hours. One plate will be incubated aerobically and the other will be incubated anaerobically in order to isolate the obligate anaerobes. The number of bacterial colonies on each plate will then be counted using serial dilution technique to find the number of colony forming units per ml (CFU/ml)
postoperative pain measurement
Time frame: 1 week
Postoperative pain will be measured using numerical rate scale (NRS) after 6, 12, 24, 48, 72 and 1 week from the end of endodontic treatment. The NRS consists of 11 point scale from 0 to 10 anchored by two extremes "No pain" and "pain as bad as could be", patient will be asked to choose the mark that represent their level of pain. Pain level will be assigned to one of 4 categorical scores: None (0); Mild (1-3); Moderate (4-6); Severe (7-10).
1 secondary outcome
bacterial load reduction
Time frame: 1 week
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 20 Aug 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.
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 Phase 2 study testing Hyalone and Calcium Hydroxide (Ca(OH)2) Intracanal Medication in people with Bacterial Load Reduction and Postoperative Pain, 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 10 inclusion and 0 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 20 Aug 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Bacterial load reductiion (time frame: 1 week). The study lists 2 primary outcomes in all. 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 20 Aug 2026.