Back to resultsEfficacy of Ozone Gel, Doxycycline Saturated Chitosan Dressing Versus Alveogyl in Pain Alleviation and Healing of Alveolar Osteitis
Primary Purpose
Osteitis, Dry Socket
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ozone gel
doxycycline hyclate saturated chitosan dressing
Sponsored by
About this trial
This is an interventional treatment trial for Osteitis
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Faculty of Dentistry, Minia UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Ozone gel
doxycycline hyclate saturated chitosan dressing
Alveogyl paste
Arm Description
(Ozene; Premier Research Labs, lp, 3500-b Wadley pl, Austin, TX, USA. 78728)
doxycycline hyclate ( Atridox 10% Tolmar Inc, USA) saturated chitosan dressing (HHD) HemCon dental dressing Pro ( Tricol Biomedical, Inc. USA)
Alveogyl paste ( Septodont, inc, france)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Healing score of the extraction socket
According to the amount of granulation tissue:
Nil: no granulation tissue
Granulation tissue in one quarter or less
Granulation tissue in 2 quarters +++ Granulation tissue in 3 quarters ++++ Granulation tissue in 4 quarters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05875506
Brief Title
Efficacy of Ozone Gel, Doxycycline Saturated Chitosan Dressing Versus Alveogyl in Pain Alleviation and Healing of Alveolar Osteitis
Official Title
Efficacy of Ozone Gel, Doxycycline Saturated Chitosan Dressing Versus Alveogyl in Pain Alleviation and Healing of Alveolar Osteitis in Diabetic Patients Double Blind Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Efficacy of ozone gel, doxycycline saturated chitosan dressing versus Alveogyl in pain alleviation and healing of alveolar osteitis in diabetic patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteitis, Dry Socket
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ozone gel
Arm Type
Experimental
Arm Description
(Ozene; Premier Research Labs, lp, 3500-b Wadley pl, Austin, TX, USA. 78728)
Arm Title
doxycycline hyclate saturated chitosan dressing
Arm Type
Experimental
Arm Description
doxycycline hyclate ( Atridox 10% Tolmar Inc, USA) saturated chitosan dressing (HHD) HemCon dental dressing Pro ( Tricol Biomedical, Inc. USA)
Arm Title
Alveogyl paste
Arm Type
Active Comparator
Arm Description
Alveogyl paste ( Septodont, inc, france)
Intervention Type
Drug
Intervention Name(s)
Ozone gel
Intervention Description
(Ozene; Premier Research Labs, lp, 3500-b Wadley pl, Austin, TX, USA. 78728) applied in dry socket
Intervention Type
Drug
Intervention Name(s)
doxycycline hyclate saturated chitosan dressing
Intervention Description
doxycycline hyclate ( Atridox 10% Tolmar Inc, USA) saturated chitosan dressing (HHD) HemCon dental dressing Pro ( Tricol Biomedical, Inc. USA) applied in dry socket
Primary Outcome Measure Information:
Title
Pain scores will be recorded on visual analog scale (VAS)
Description
visual analog scale (VAS) is a scale from 0 to 10. 0 indicates no pain while indicates extensive unbearable pain
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Healing score of the extraction socket
Description
According to the amount of granulation tissue:
Nil: no granulation tissue
Granulation tissue in one quarter or less
Granulation tissue in 2 quarters +++ Granulation tissue in 3 quarters ++++ Granulation tissue in 4 quarters
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tarek Abdelbarry, Doctorate
Phone
00201025483600
Email
drtarekabdelbary05@gmail.com
Facility Information:
Facility Name
Faculty of Dentistry, Minia University
City
Minya
ZIP/Postal Code
2431412
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarek Abdelbarry, Doctorate
Phone
00201025483600
Email
drtarekabdelbary05@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Ozone Gel, Doxycycline Saturated Chitosan Dressing Versus Alveogyl in Pain Alleviation and Healing of Alveolar Osteitis
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