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 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

Study Overview

• Status: Completed
• Conditions: Osteitis; Dry Socket
• Intervention / Treatment: Drug: Ozone gel; Drug: doxycycline hyclate saturated chitosan dressing

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 2431412
    • Faculty of dentistry, Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing score of the extraction socket	According to the amount of granulation tissue: Nil: no granulation tissue; Granulation tissue in one quarter or lessGranulation tissue in 2 quarters +++ Granulation tissue in 3 quarters ++++ Granulation tissue in 4 quarters	21 days

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Osteitis; Dry Socket; Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants; Antimetabolites; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Chelating Agents; Sequestering Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Doxycycline; Chitosan
• Other Study ID Numbers: 713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No