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

Dry Socket Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875506
• Other study ID #: 713
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: May 2023
• Source: Minia University
• Contact: Tarek Abdelbarry, Doctorate
• Phone: 00201025483600
• Email: drtarekabdelbary05[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Socket
• Osteitis

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Minia University	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	21 days