In Vivo Comparative Study of Calcium Hydroxide and Triple Antibiotic Paste in Intracanal Medicament in Emergency Pain Reduction

NCT ID: NCT06174909

Last Updated: 2023-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-08-10

Brief 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 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

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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".

Group Type: EXPERIMENTAL

Calcium Hydroxide

Intervention Type: DRUG

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 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".

Group Type: ACTIVE_COMPARATOR

Triple Antibiotic paste

Intervention Type: DRUG

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

Interventions

Calcium Hydroxide

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

Intervention Type: DRUG

Triple Antibiotic paste

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pakistan Institute of Medical Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ahsen amin

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Dentistry

Islamabad, , Pakistan

Countries

Pakistan

Other Identifiers

SOD/ERB/2022

Identifier Type: -

Identifier Source: org_study_id