NCT06174909

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

September 9, 2023

Last Update Submit

December 8, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    Pain after root canal treatment

    Immediately after the procedure

Study Arms (2)

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".

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".

Drug: Triple Antibiotic paste

Interventions

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

Calcium Hydroxide

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

Triple antibiotic Paste

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry

Islamabad, 0920, Pakistan

Location

MeSH Terms

Conditions

Pain

Interventions

Calcium Hydroxide

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 9, 2023

First Posted

December 18, 2023

Study Start

November 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 10, 2023

Last Updated

December 18, 2023

Record last verified: 2023-12

Locations