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Efficacy of Ozone Gel, Doxycycline Saturated Chitosan Dressing Versus Alveogyl in Pain Alleviation and Healing of Alveolar Osteitis

Sponsor
Minia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05875506
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
4
Anticipated Duration (Months)
14.8
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Ozone gel
  • Drug: doxycycline hyclate saturated chitosan dressing
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ozone gel

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

Drug: Ozone gel
(Ozene; Premier Research Labs, lp, 3500-b Wadley pl, Austin, TX, USA. 78728) applied in dry socket
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
doxycycline hyclate ( Atridox 10% Tolmar Inc, USA) saturated chitosan dressing (HHD) HemCon dental dressing Pro ( Tricol Biomedical, Inc. USA) applied in dry socket
Active Comparator: Alveogyl paste

Alveogyl paste ( Septodont, inc, france)

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

Drug: doxycycline 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

Outcome Measures

Primary Outcome Measures

  1. Pain scores will be recorded on visual analog scale (VAS) [7 days]

    visual analog scale (VAS) is a scale from 0 to 10. 0 indicates no pain while indicates extensive unbearable pain

Secondary Outcome Measures

  1. Healing score of the extraction socket [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, Minia University Minya Egypt 2431412

Sponsors and Collaborators

  • Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tarek Abdelbarry, Lecturer of Oral and Maxillofacial Surgery, Minia University
ClinicalTrials.gov Identifier:
NCT05875506
Other Study ID Numbers:
  • 713
First Posted:
May 25, 2023
Last Update Posted:
May 31, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Osteitis
Dry Socket
Doxycycline
Chitosan

Study Results

No Results Posted as of May 31, 2023