Periapical PeriodontitisNCT07252258
Comparison of Frequency of Calcium Hydroxide Mixed With 0.2% Chlorhexidine Versus Saline as Intracanal Medicament in Periapical Periodontitis-A Randomized Controlled Trial
A study testing Calcium Hydroxide + Normal Saline and Calcium Hydroxide + 0.2% Chlorhexidine Digluconate in people with Periapical Periodontitis, run by Aqsa Afzal at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to compare the effectiveness of calcium hydroxide mixed with 0.2% chlorhexidine digluconate versus calcium hydroxide mixed with saline as intracanal medicaments in reducing postoperative pain in patients with apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periapical Periodontitis
- What is being tested?
- Calcium Hydroxide + Normal Saline and Calcium Hydroxide + 0.2% Chlorhexidine Digluconate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2025to 15 Feb 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients age 18 or above 18 year old (to have complete apex formation)
- Anterior teeth with apical periodontitis (simple root canal morphology)
- Patients whose medical history does not include a history of certain illnesses, such as HIV, heart disease, or epilepsy (conditions that can affect a patient's rate of healing).
Who cannot join
- Patient allergic to chlorhexidine digluconate and Calcium hydroxide assessed by history.
- Tooth having necrotic pulp on radiographic examination and electric pulp tester.
- Multiple rooted teeth.
- Previously root canal treated tooth because of procedural errors and periapical infection.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Saidu College of Dentistry Swat
Swāt, Khyber Pakhtunkhwa, 19200
About this study
This randomized controlled trial aims to compare the effectiveness of calcium hydroxide mixed with 0.2% chlorhexidine digluconate versus calcium hydroxide mixed with saline as intracanal medicaments in reducing postoperative pain in patients with apical periodontitis. A total of 80 adult patients with anterior teeth diagnosed with apical periodontitis will be randomly assigned to two equal groups. After standard chemomechanical root canal preparation, Group A will receive calcium hydroxide with saline, while Group B will receive calcium hydroxide with 0.2% chlorhexidine. Postoperative pain will be assessed using a 10-point Visual Analogue Scale (VAS) at 12, 24, and 48 hours. The primary outcome is the frequency and severity of pain at 24 hours. Data will be analyzed using chi-square or Fisher's exact test, with a significance level of p < 0.05. The study aims to determine whether the addition of chlorhexidine improves the analgesic and antimicrobial effectiveness of calcium hydroxide during root canal treatment.
- Conditions
- Periapical Periodontitis
- Being tested
- Calcium Hydroxide + Normal Saline, Calcium Hydroxide + 0.2% Chlorhexidine Digluconate
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide + Normal SalineDrug
Calcium hydroxide powder mixed with sterile normal saline and placed inside the root canal as intracanal medicament.
Calcium Hydroxide + 0.2% Chlorhexidine DigluconateDrug
Calcium hydroxide powder combined with 0.2% chlorhexidine solution and placed inside the root canal as intracanal medicament.
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide + Saline | Placebo comparator | Participants in this arm will receive intracanal medicament consisting of calcium hydroxide mixed with normal saline after standard chemomechanical root canal preparation. Temporary restoration will be placed, and postoperative pain will be assessed at designated intervals Receives: Drug: Calcium Hydroxide + Normal Saline |
| Calcium Hydroxide + 0.2% Chlorhexidine | Experimental | Participants in this arm will receive intracanal medicament consisting of calcium hydroxide mixed with 0.2% chlorhexidine digluconate following standard root canal procedures. Temporary restoration will be placed, and postoperative pain will be evaluated. Receives: Drug: Calcium Hydroxide + 0.2% Chlorhexidine Digluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome measure
Postoperative pain will be assessed using a 10-point Visual Analogue Scale (VAS), where 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.
Measured: 24 hours after placement of intracanal medicament (pain also recorded at 12 and 48 hours, but final outcome measured at 24 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start15 Jul 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aqsa Afzal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aqsa Afzal, College of Physicians and Surgeons Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252258
- Sponsor's protocol ID
- 118-ERB/023
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 26 Nov 2025
- 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 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Frequency of Calcium Hydroxide Mixed With 0.2% Chlorhexidine Versus Saline as Intracanal Medicament in Periapical Periodontitis-A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07252258
- Acronym / sponsor ID
- 118-ERB/023
- Conditions
- Periapical Periodontitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aqsa AfzalUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 26 Nov 2025 (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 trial aims to compare the effectiveness of calcium hydroxide mixed with 0.2% chlorhexidine digluconate versus calcium hydroxide mixed with saline as intracanal medicaments in reducing postoperative pain in patients with apical periodontitis. A total of 80 adult patients with anterior teeth diagnosed with apical periodontitis will be randomly assigned to two equal groups. After standard chemomechanical root canal preparation, Group A will receive calcium hydroxide with saline, while Group B will receive calcium hydroxide with 0.2% chlorhexidine. Postoperative pain will be assessed using a 10-point Visual Analogue Scale (VAS) at 12, 24, and 48 hours. The primary outcome is the frequency and severity of pain at 24 hours. Data will be analyzed using chi-square or Fisher's exact test, with a significance level of p < 0.05. The study aims to determine whether the addition of chlorhexidine improves the analgesic and antimicrobial effectiveness of calcium hydroxide during root canal treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxide + Saline | Placebo comparator | Drug: Calcium Hydroxide + Normal SalineParticipants in this arm will receive intracanal medicament consisting of calcium hydroxide mixed with normal saline after standard chemomechanical root canal preparation. Temporary restoration will be placed, and postoperative pain will be assessed at designated intervals |
| Calcium Hydroxide + 0.2% Chlorhexidine | Experimental | Drug: Calcium Hydroxide + 0.2% Chlorhexidine DigluconateParticipants in this arm will receive intracanal medicament consisting of calcium hydroxide mixed with 0.2% chlorhexidine digluconate following standard root canal procedures. Temporary restoration will be placed, and postoperative pain will be evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Patients age 18 or above 18 year old (to have complete apex formation)
Key exclusion criteria (4 listed)
- Patient allergic to chlorhexidine digluconate and Calcium hydroxide assessed by history.
- Tooth having necrotic pulp on radiographic examination and electric pulp tester.
- Multiple rooted teeth.
- Previously root canal treated tooth because of procedural errors and periapical infection.
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 Hydroxide + Normal SalineCalcium hydroxide powder mixed with sterile normal saline and placed inside the root canal as intracanal medicament. | Drug | Calcium Hydroxide + Saline |
| Calcium Hydroxide + 0.2% Chlorhexidine DigluconateCalcium hydroxide powder combined with 0.2% chlorhexidine solution and placed inside the root canal as intracanal medicament. | Drug | Calcium Hydroxide + 0.2% Chlorhexidine |
Primary outcome
primary outcome measure
Time frame: 24 hours after placement of intracanal medicament (pain also recorded at 12 and 48 hours, but final outcome measured at 24 hours).
Postoperative pain will be assessed using a 10-point Visual Analogue Scale (VAS), where 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.
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 26 Nov 2025.
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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 Calcium Hydroxide + Normal Saline and Calcium Hydroxide + 0.2% Chlorhexidine Digluconate in people with Periapical Periodontitis, run by Aqsa Afzal at 1 site in Pakistan.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
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?
primary outcome measure (time frame: 24 hours after placement of intracanal medicament (pain also recorded at 12 and 48 hours, but final outcome measured at 24 hours).). 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 26 Nov 2025.