Efficacy of Ozone Gel, Doxycycline Saturated Chitosan Dressing Versus Alveogyl
1 other identifier
interventional
60
1 country
1
Brief Summary
Efficacy of ozone gel, doxycycline saturated chitosan dressing versus Alveogyl in pain alleviation and healing of alveolar osteitis in diabetic patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
May 16, 2023
CompletedFirst Posted
Study publicly available on registry
May 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedJanuary 6, 2025
May 1, 2023
3 months
May 16, 2023
January 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Pain scores will be recorded on visual analog scale (VAS)
visual analog scale (VAS) is a scale from 0 to 10. 0 indicates no pain while indicates extensive unbearable pain
7 days
Secondary Outcomes (1)
Healing score of the extraction socket
21 days
Study Arms (3)
Ozone gel
EXPERIMENTAL(Ozene; Premier Research Labs, lp, 3500-b Wadley pl, Austin, TX, USA. 78728)
doxycycline hyclate saturated chitosan dressing
EXPERIMENTALdoxycycline hyclate ( Atridox 10% Tolmar Inc, USA) saturated chitosan dressing (HHD) HemCon dental dressing Pro ( Tricol Biomedical, Inc. USA)
Alveogyl paste
ACTIVE COMPARATORAlveogyl paste ( Septodont, inc, france)
Interventions
(Ozene; Premier Research Labs, lp, 3500-b Wadley pl, Austin, TX, USA. 78728) applied in dry socket
doxycycline hyclate ( Atridox 10% Tolmar Inc, USA) saturated chitosan dressing (HHD) HemCon dental dressing Pro ( Tricol Biomedical, Inc. USA) applied in dry socket
Eligibility Criteria
You may qualify if:
- Patients over 20 years and under 60 years of age
- DM controlled by medication, presented to outpatient clinic with signs and symptoms of dry socket
- Only participant that are willing to control and record blood glucose level throughout the study period
You may not qualify if:
- Patients with any significant medical condition (besides DM)
- Alcoholic individuals
- Patients on drugs that affect the central nervous systems
- Patients who reported the use of drugs that might interfere with pain sensitivity
- Pregnant and lactating women
- Hypersensitivity to local anesthetics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Faculty of Dentistry, Minia University
Minya, 2431412, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Oral and Maxillofacial Surgery
Study Record Dates
First Submitted
May 16, 2023
First Posted
May 25, 2023
Study Start
May 1, 2023
Primary Completion
August 1, 2023
Study Completion
September 1, 2023
Last Updated
January 6, 2025
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share