OsteitisNCT05875506
Efficacy of Ozone Gel, Doxycycline Saturated Chitosan Dressing Versus Alveogyl
A study testing Ozone gel and doxycycline hyclate saturated chitosan dressing in people with Osteitis and Dry Socket, run by Minia University at 1 site in Egypt.
Trial summary
Efficacy of ozone gel, doxycycline saturated chitosan dressing versus Alveogyl in pain alleviation and healing of alveolar osteitis in diabetic patients Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteitis, Dry Socket
- What is being tested?
- Ozone gel and doxycycline hyclate saturated chitosan dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Efficacy of ozone gel, doxycycline saturated chitosan dressing versus Alveogyl in pain alleviation and healing of alveolar osteitis in diabetic patients
- Conditions
- Osteitis, Dry Socket
- Being tested
- Ozone gel, doxycycline hyclate saturated chitosan dressing
- Medical subject headings
- Osteitis, Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone gelDrug
(Ozene; Premier Research Labs, lp, 3500-b Wadley pl, Austin, TX, USA. 78728) applied in dry socket
doxycycline hyclate saturated chitosan dressingDrug
doxycycline hyclate ( Atridox 10% Tolmar Inc, USA) saturated chitosan dressing (HHD) HemCon dental dressing Pro ( Tricol Biomedical, Inc. USA) applied in dry socket
| Study group | Role | What they receive |
|---|---|---|
| Ozone gel | Experimental | (Ozene; Premier Research Labs, lp, 3500-b Wadley pl, Austin, TX, USA. 78728) Receives: Drug: Ozone gel |
| doxycycline hyclate saturated chitosan dressing | Experimental | doxycycline hyclate ( Atridox 10% Tolmar Inc, USA) saturated chitosan dressing (HHD) HemCon dental dressing Pro ( Tricol Biomedical, Inc. USA) Receives: Drug: doxycycline hyclate saturated chitosan dressing |
| Alveogyl paste | Active comparator | Alveogyl paste ( Septodont, inc, france) Receives: Drug: Ozone gel; Drug: doxycycline hyclate saturated chitosan dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (1)
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
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 May 2023
- Primary completion1 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteitisStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Abdelbarry, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875506
- Sponsor's protocol ID
- 713
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05875506
- Acronym / sponsor ID
- 713
- Conditions
- Osteitis, Dry Socket
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy of ozone gel, doxycycline saturated chitosan dressing versus Alveogyl in pain alleviation and healing of alveolar osteitis in diabetic patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ozone gel | Experimental | Drug: Ozone gel(Ozene; Premier Research Labs, lp, 3500-b Wadley pl, Austin, TX, USA. 78728) |
| doxycycline hyclate saturated chitosan dressing | Experimental | Drug: doxycycline hyclate saturated chitosan dressingdoxycycline hyclate ( Atridox 10% Tolmar Inc, USA) saturated chitosan dressing (HHD) HemCon dental dressing Pro ( Tricol Biomedical, Inc. USA) |
| Alveogyl paste | Active comparator | Drug: Ozone gel, Drug: doxycycline hyclate saturated chitosan dressingAlveogyl paste ( Septodont, inc, france) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozone gel(Ozene; Premier Research Labs, lp, 3500-b Wadley pl, Austin, TX, USA. 78728) applied in dry socket | Drug | Alveogyl paste, Ozone gel |
| doxycycline hyclate saturated chitosan dressingdoxycycline hyclate ( Atridox 10% Tolmar Inc, USA) saturated chitosan dressing (HHD) HemCon dental dressing Pro ( Tricol Biomedical, Inc. USA) applied in dry socket | Drug | Alveogyl paste, doxycycline hyclate saturated chitosan dressing |
Primary outcome
Pain scores will be recorded on visual analog scale (VAS)
Time frame: 7 days
visual analog scale (VAS) is a scale from 0 to 10. 0 indicates no pain while indicates extensive unbearable pain
1 secondary outcome
Healing score of the extraction socket
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Osteitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozone gel and doxycycline hyclate saturated chitosan dressing in people with Osteitis and Dry Socket, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores will be recorded on visual analog scale (VAS) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.