Influence of Calcium Hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra Canal Medicaments in Retreatment Cases
med
1 other identifier
interventional
24
0 countries
N/A
Brief Summary
Influence of Calcium hydroxide Chlorhexidine Combination vs. Calcium Hydroxide as an Intra canal Medicamentson Postoperative flare -up following two-Visit Endodontic Retreatment cases
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Jul 2017
Shorter than P25 for early_phase_1
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
First Submitted
Initial submission to the registry
July 3, 2017
CompletedFirst Posted
Study publicly available on registry
July 6, 2017
CompletedStudy Start
First participant enrolled
July 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2018
CompletedJuly 6, 2017
July 1, 2017
2 months
July 3, 2017
July 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative flare up (pain and swelling ) will be measured as below after 7 days from first visit postoperative pain
categorical ( 4 points) 1. no pain 2. Mild pain: recognizable but not discomforting pain that required no analgesics. 3. Moderate pain: discomforting but bearable pain(analgesics if used were effective in relieving pain) 4. Severe pain: difficult to bear (analgesics were effective in relieving pain). Patients with severe postoperative pain and/or occurrence of swelling were classified as flare-ups.3 Objectively : percussion test
7 days
Study Arms (2)
calcium hydroxide and chlorhexidine
ACTIVE COMPARATORRemoval of old root canal filling and placing calcium hydroxide and chlorehexidine as intracanal medication
calcium hydroxide
ACTIVE COMPARATORRemoval of old root canal filling and placing calcium hydroxide as intracanal medication
Interventions
placement of calcium hydroxide and chlorhexidine as intracanal medicament after removal of old filling and mechanical preparation of root canal
placement of calcium hydroxide as intracanal medicament after removal of old filling and mechanical preparation of root canal
Eligibility Criteria
You may qualify if:
- Patients' needs retreatment.
- Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
- Age range is between 20 and 50 years.
- Patients who can understand the categorical tool (points)for measurement
- Patients able to sign informed consent.
You may not qualify if:
- Complicating systemic disease
- Having severe pain and/or acute apical abscesses
- Being under 18 years of age
- Using antibiotics or corticosteroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Geraldine M Ahmed, Assistant professor
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
July 3, 2017
First Posted
July 6, 2017
Study Start
July 8, 2017
Primary Completion
September 8, 2017
Study Completion
July 8, 2018
Last Updated
July 6, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share