ClinicalTrials.gg
CompletedNCT05875506Updated Jan 6, 2025

Efficacy of Ozone Gel, Doxycycline Saturated Chitosan Dressing Versus Alveogyl

An interventional study of Ozone gel and doxycycline hyclate saturated chitosan dressing in Osteitis and Dry Socket, sponsored by Minia University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-06.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

Efficacy of ozone gel, doxycycline saturated chitosan dressing versus Alveogyl in pain alleviation and healing of alveolar osteitis in diabetic patients

02

Conditions studied

  • Osteitis
  • Dry Socket

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03

In context

Osteitis

11 studies on the registry are indexed under Osteitis; 1 is open to participants now.

Browse Osteitis studies →

Lead sponsor

Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • to local anesthetics
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Ozone gel

    (Ozene; Premier Research Labs, lp, 3500-b Wadley pl, Austin, TX, USA. 78728)

    Drug: Ozone gel

  • Experimental
    doxycycline hyclate saturated chitosan dressing

    doxycycline hyclate ( Atridox 10% Tolmar Inc, USA) saturated chitosan dressing (HHD) HemCon dental dressing Pro ( Tricol Biomedical, Inc. USA)

    Drug: doxycycline hyclate saturated chitosan dressing

  • Active comparator
    Alveogyl paste

    Alveogyl paste ( Septodont, inc, france)

    Drug: Ozone gel · Drug: doxycycline hyclate saturated chitosan dressing

Interventions

  • (Ozene; Premier Research Labs, lp, 3500-b Wadley pl, Austin, TX, USA. 78728) applied in dry socket

  • Drugdoxycycline hyclate saturated chitosan dressing

    doxycycline hyclate ( Atridox 10% Tolmar Inc, USA) saturated chitosan dressing (HHD) HemCon dental dressing Pro ( Tricol Biomedical, Inc. USA) applied in dry socket

06

What researchers measure

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

    Time frame: 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

    Time frame: 21 days

07

Study locations

1 site
  • Faculty of Dentistry, Minia University
    Minya, 2431412, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2023 to primary completion in Aug 2023, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2023
First posted
May 25, 2023
StartActual
May 1, 2023
Primary completionActual
Aug 1, 2023
CompletionActual
Sep 1, 2023
Last update
Jan 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05875506
Lead sponsor
Minia University
Responsible party
Tarek Abdelbarry (Lecturer of Oral and Maxillofacial Surgery, Minia University) — Principal investigator
First posted
May 25, 2023
Start date
May 1, 2023
Primary completion
Aug 1, 2023
Completion
Sep 1, 2023
Last update
Jan 6, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ozone

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