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Completed

NCT Number: NCT05875506

Efficacy of Ozone Gel, Doxycycline Saturated Chitosan Dressing Versus Alveogyl

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

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Key information

Conditions

Osteitis Bone Diseases Dry Socket Mouth Diseases Musculoskeletal Diseases Stomatognathic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Minia University

Minya, 2431412, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ozone gel

Drug

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

doxycycline hyclate saturated chitosan dressing

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Healing score of the extraction socket

    Time frame: 21 days

    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

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 25, 2023
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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