Ozone Oil-based Gel and CHX Gel After Lower Third Molar R... | NCT07549672

Studies
Ozone Oil-based Gel and CHX Gel After Lower Third Molar Removal

NCT07549672

Sponsor

Cairo University

Status

Active, not recruiting

Last Update Posted

Apr 28, 2026Actual

Enrollment

100Actual

Phase

Early Phase 1

Conditions

Pain
Dry Socket

Interventions

Ozone Oil-based Gel

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2023Actual

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Sep 1, 2026Estimated

First Submitted Date

Apr 9, 2026

First Submission Date that Met QC Criteria

Apr 22, 2026

First Posted Date

Apr 24, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2026

Last Update Posted Date

Apr 28, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nahla Mahmoud Awad, associate professor of oral and maxillofacial surgery, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Overall, 100 patients of both genders were included in the study, with indication of surgical extraction of lower third molar, positioned similarly after being clinically and radiographically checked by X-ray and orthopantomography. Each patient was subjected to both groups in separate sessions: treated with ozone gas and with CHX gel 1%. Data on pain intensity, number of taken analgesics- painkillers, and dry socket were recorded for 48 h and at Day 7

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group and control group	Experimental	study group	Drug: Ozone Oil-based Gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ozone Oil-based Gel	Drug	Overall, 30 patients of both genders were included in the study, with indication of surgical extraction of lower third molar, positioned similarly after being clinically and radiographically checked by X-ray and orthopantomography. Each patient was subjected to both groups in separate sessions: treated with ozone gas and with CHX gel 1%. Data on pain intensity, number of taken analgesics- painkillers, and dry socket were recorded for 48 h and at Day 7

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain severity	pain scale ( VAS ; visual analogue scale) (1-10)	7 days

Secondary Outcomes

Measure	Description	Time Frame
dry socket incidence	bare socket (binary yes/no)	15 daays

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with third impacted bilateral molars, symmetrically in the same position, position evaluated by radiography.
Patients in whom operative extraction of third molars is indicated with the creation of a mucoperiosteal flap.
Patients regardless of gender.

Exclusion Criteria:

Voluntary exclusion of the patient.
lack of cooperation in any of the work phase

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ASSOCIATE PROFESSOR cairo university		Cairo	Cairo Governorate	12515	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D004368	Dry Socket

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description