PainNCT06174909
In Vivo Comparative Study of Calcium Hydroxide and Triple Antibiotic Paste in Intracanal Medicament in Emergency Pain Reduction
A study testing Calcium Hydroxide and Triple Antibiotic paste in people with Pain, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
Interappointment pain is a universal concern for clinician and patients alike which remain a significant challenge for dentalprofessional.The purpose of this study was to evaluate the effects of calcium hydroxide, and triple antibiotic paste as intra-canal medicaments in emergency pain reduction in patients undergoing… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Calcium Hydroxide and Triple Antibiotic paste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2022to 10 Aug 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Patients who agree to particapte in study 2. Patient with age between 18 to 60 years 3. single rooted teeth with closed apices included in the study 4. Patient diagnosed with Necrosed tooth with acute apical periodontitis will be included in the study.
Who cannot join
- 1. Teeth with incomplete root formation. 2. Severe periodontal problem. 3. Vertical or horizontal root fractures were excluded from the study 4. Retreatment cases will not included in study. 5. Patients with systemic problems, for example, diabetes and autoimmune disease, and so on, will not be selected for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo Comparative Study Calcium Hydroxide and Triple Antibiotic Paste in Emergency Pain Reduction
Interappointment pain is a universal concern for clinician and patients alike which remain a significant challenge for dentalprofessional.The purpose of this study was to evaluate the effects of calcium hydroxide, and triple antibiotic paste as intra-canal medicaments in emergency pain reduction in patients undergoing endodontic treatment .
Read the detailed description
Before commencing treatment, the complete procedure was explained to the patients and consent was obtained. Local anesthesia was administered, and the tooth was isolated under rubber dam. Access cavity preparation was done, and canals were explored using endodontic explorer (DG-16,). Working length was determined with No. 15 K-files using apex locater and was confirmed with radiovisiography . Cleaning and shaping were along with copious irrigation using 3% NaOCl and 0.9% saline . Canals will be dried and one of the following two medicaments will be inserted into the canals in random sequences
Group 1 :Calcium Hydroxide:
CH was placed as an intracanal medicament. Atotal of 100 mg of CH powder was dispensed and mixed with one drop of pro-pylene glycol on a clean and dry glass slab to prepare a thick paste-like consistency. This paste was carried into the canal , and access opening was restored temporarily with temporary cement
Group 2: Triple antibiotic paste:
It was prepared by removing the coating and crushing of antibiotic ciprofloxacin500mg,metronidazole 400mg,, and clindamycin tablets separately using a mortar and pestle. The crushed powder was passed through a fine sieve to remove heavy filler particles and obtain a fine powder. The ciprofloxacin, metronidazole, and clindamycin powders thus obtained were weighed separately and mixed in a 1:3 proportions respectively,to obtain triple antiobiotic mixture.A total 100 mg of this Ta mixture was dispensed and mixed with one drop of propylene glycol to get a thick paste-like consistency. This paste was placed gently compacted into the canal , and access opening was restored with temporary cement Before dismissal ,no antiobiotics will be prescribed and the patients who had been taking antibiotics will be recorded.Patient will be requested to stop antibiotics.They will be requested to stop analgesic.The preoperative pain experienced on the previous night will be recorded using visual analogue scale.Patient will be then instructed to record the degree of pain experienced after 2nd day ,7th day and 15 day postoperatively
- Conditions
- Pain
- Being tested
- Calcium Hydroxide, Triple Antibiotic paste
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium HydroxideDrug
After completion of canal and shaping ,canal was dried and CH was placed as an intracanal medicament. A total of 100 mg of CH powder was dispensed and mixed with one drop of pro-pylene glycol on a clean and dry glass slab to prepare a thick paste-like consistency. This paste was carried into the canal and access opening was restored temporarily with temporary cement
Triple Antibiotic pasteDrug
After completion of cleaning and shaping ,canal was dried and tripe antibiotic was placed as intracanal medicament.It was prepared by removing the coating and crushing of antibiotic ciprofloxacin500mg,metronidazole 400mg,, and clindamycin tablets separately using a mortar and pestle. It was prepared by removing the coating and crushing of antibiotic ciprofloxacin500mg,metronidazole 400mg,, and clindamycin tablets separately using a mortar and pestle. This paste was placed gently compacted into the canal and access opening was restored with temporary cement
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxide | Experimental | Calcium hydroxide has antimicrobial properties and tissue altering effect,used into root canals for the purpose of inhibiting coronal invasion of bacteria from the oral cavity". Receives: Drug: Calcium Hydroxide |
| Triple antibiotic Paste | Active comparator | Triple antibiotic paste is combination of ciprofloxcin,metronidazole,and minocycline,used into root canals for the purpose of inhibiting coronal invasion of bacteria from the oral cavity". Receives: Drug: Triple Antibiotic paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Pain after root canal treatment
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Nov 2022
- Primary completion1 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahsen amin, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174909
- Sponsor's protocol ID
- SOD/ERB/2022
- Status last verified
- Dec 2023
- First submitted
- 9 Sep 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Comparative Study Calcium Hydroxide and Triple Antibiotic Paste in Emergency Pain Reduction
- ClinicalTrials.gov ID
- NCT06174909
- Acronym / sponsor ID
- SOD/ERB/2022
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 18 Dec 2023 (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.
Interappointment pain is a universal concern for clinician and patients alike which remain a significant challenge for dentalprofessional.The purpose of this study was to evaluate the effects of calcium hydroxide, and triple antibiotic paste as intra-canal medicaments in emergency pain reduction in patients undergoing endodontic treatment .
Detailed description
Before commencing treatment, the complete procedure was explained to the patients and consent was obtained. Local anesthesia was administered, and the tooth was isolated under rubber dam. Access cavity preparation was done, and canals were explored using endodontic explorer (DG-16,). Working length was determined with No. 15 K-files using apex locater and was confirmed with radiovisiography . Cleaning and shaping were along with copious irrigation using 3% NaOCl and 0.9% saline . Canals will be dried and one of the following two medicaments will be inserted into the canals in random sequences
Group 1 :Calcium Hydroxide:
CH was placed as an intracanal medicament. Atotal of 100 mg of CH powder was dispensed and mixed with one drop of pro-pylene glycol on a clean and dry glass slab to prepare a thick paste-like consistency. This paste was carried into the canal , and access opening was restored temporarily with temporary cement
Group 2: Triple antibiotic paste:
It was prepared by removing the coating and crushing of antibiotic ciprofloxacin500mg,metronidazole 400mg,, and clindamycin tablets separately using a mortar and pestle. The crushed powder was passed through a fine sieve to remove heavy filler particles and obtain a fine powder. The ciprofloxacin, metronidazole, and clindamycin powders thus obtained were weighed separately and mixed in a 1:3 proportions respectively,to obtain triple antiobiotic mixture.A total 100 mg of this Ta mixture was dispensed and mixed with one drop of propylene glycol to get a thick paste-like consistency. This paste was placed gently compacted into the canal , and access opening was restored with temporary cement Before dismissal ,no antiobiotics will be prescribed and the patients who had been taking antibiotics will be recorded.Patient will be requested to stop antibiotics.They will be requested to stop analgesic.The preoperative pain experienced on the previous night will be recorded using visual analogue scale.Patient will be then instructed to record the degree of pain experienced after 2nd day ,7th day and 15 day postoperatively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxide | Experimental | Drug: Calcium HydroxideCalcium hydroxide has antimicrobial properties and tissue altering effect,used into root canals for the purpose of inhibiting coronal invasion of bacteria from the oral cavity". |
| Triple antibiotic Paste | Active comparator | Drug: Triple Antibiotic pasteTriple antibiotic paste is combination of ciprofloxcin,metronidazole,and minocycline,used into root canals for the purpose of inhibiting coronal invasion of bacteria from the oral cavity". |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients who agree to particapte in study 2. Patient with age between 18 to 60 years 3. single rooted teeth with closed apices included in the study 4. Patient diagnosed with Necrosed tooth with acute apical periodontitis will be included in the study.
Key exclusion criteria (1 listed)
- 1. Teeth with incomplete root formation. 2. Severe periodontal problem. 3. Vertical or horizontal root fractures were excluded from the study 4. Retreatment cases will not included in study. 5. Patients with systemic problems, for example, diabetes and autoimmune disease, and so on, will not be selected for 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 HydroxideAfter completion of canal and shaping ,canal was dried and CH was placed as an intracanal medicament. A total of 100 mg of CH powder was dispensed and mixed with one drop of pro-pylene glycol on a clean and dry glass slab to prepare a thick paste-like consistency. This paste was carried into the canal and access opening was restored temporarily with temporary cement | Drug | Calcium Hydroxide |
| Triple Antibiotic pasteAfter completion of cleaning and shaping ,canal was dried and tripe antibiotic was placed as intracanal medicament.It was prepared by removing the coating and crushing of antibiotic ciprofloxacin500mg,metronidazole 400mg,, and clindamycin tablets separately using a mortar and pestle. It was prepared by removing the coating and crushing of antibiotic ciprofloxacin500mg,metronidazole 400mg,, and clindamycin tablets separately using a mortar and pestle. This paste was placed gently compacted into the canal and access opening was restored with temporary cement | Drug | Triple antibiotic Paste |
Primary outcome
Postoperative pain
Time frame: Immediately after the procedure
Pain after root canal 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 18 Dec 2023.
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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 and Triple Antibiotic paste in people with Pain, run by Pakistan Institute of Medical Sciences 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 1 inclusion and 1 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 18 Dec 2023. 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. 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?
Postoperative pain (time frame: Immediately after the procedure). 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 18 Dec 2023.