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

Study Overview
=================
Brief Summary
-----------------
Efficacy of ozone gel, doxycycline saturated chitosan dressing versus Alveogyl in pain alleviation and healing of alveolar osteitis in diabetic patients

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

Conditions
-----------------
Osteitis, Dry Socket

Intervention / Treatment
-----------------
* Drug: Ozone gel
* Drug: doxycycline hyclate saturated chitosan dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ozone gel<br>(Ozene; Premier Research Labs, lp, 3500-b Wadley pl, Austin, TX, USA. 78728) | Drug: Ozone gel<br>* (Ozene; Premier Research Labs, lp, 3500-b Wadley pl, Austin, TX, USA. 78728) applied in dry socket<br>|
| Experimental: doxycycline hyclate saturated chitosan dressing<br>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<br>* doxycycline hyclate ( Atridox 10% Tolmar Inc, USA) saturated chitosan dressing (HHD) HemCon dental dressing Pro ( Tricol Biomedical, Inc. USA) applied in dry socket<br>|
| Active Comparator: Alveogyl paste<br>Alveogyl paste ( Septodont, inc, france) | Drug: Ozone gel<br>* (Ozene; Premier Research Labs, lp, 3500-b Wadley pl, Austin, TX, USA. 78728) applied in dry socket<br>Drug: doxycycline hyclate saturated chitosan dressing<br>* doxycycline hyclate ( Atridox 10% Tolmar Inc, USA) saturated chitosan dressing (HHD) HemCon dental dressing Pro ( Tricol Biomedical, Inc. USA) applied in dry socket<br>|

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 less Granulation tissue in 2 quarters +++ Granulation tissue in 3 quarters ++++ Granulation tissue in 4 quarters | 21 days |