- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06174909
In Vivo Comparative Study of Calcium Hydroxide and Triple Antibiotic Paste in Intracanal Medicament in Emergency Pain Reduction
In Vivo Comparative Study Calcium Hydroxide and Triple Antibiotic Paste in Emergency Pain Reduction
Study Overview
Status
Conditions
Intervention / 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Islamabad, Pakistan, 0920
- School of Dentistry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Calcium Hydroxide
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".
|
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
|
Active Comparator: Triple antibiotic Paste
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".
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain
Time Frame: Immediately after the procedure
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Pain after root canal treatment
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Immediately after the procedure
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOD/ERB/2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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