Colibricare Efficacy on Oral Surgical Procedures/Extracti... | NCT07638930

Studies
Colibricare Efficacy on Oral Surgical Procedures/Extraction Wound and Gingiva Retraction

NCT07638930

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jun 11, 2026Actual

Enrollment

124Actual

Phase

Not Applicable

Conditions

Bleeding
Pain

Interventions

wisdoms' surgical extractions

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

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 26, 2022Actual

Primary Completion Date

May 26, 2022Actual

Completion Date

May 26, 2026Actual

First Submitted Date

Jun 5, 2026

First Submission Date that Met QC Criteria

Jun 5, 2026

First Posted Date

Jun 10, 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

Jun 9, 2026

Last Update Posted Date

Jun 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this randomized, three-arm trial, 120 patients undergoing wisdoms' extractions were assigned to control (gauze pressure application), commercial sponge, or Coli-sorb® groups. Outcomes included time to hemostasis, ease of placement, pain (VAS), facial swelling, and wound healing, assessed on days 1, 7, and 6 weeks.

Detailed Description

Colisorb® is a safe, efficient, and biocompatible hemostatic agent, providing rapid bleeding control, reduced pain, and enhanced healing, outperforming conventional gauze and commercial alternatives.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colisorb	Experimental	study arm	Procedure: wisdoms' surgical extractions
gelatin sponge	Experimental	study	Procedure: wisdoms' surgical extractions
gauze pressure	Placebo Comparator	control arm	Procedure: wisdoms' surgical extractions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
wisdoms' surgical extractions	Procedure	surgical removal of wisdoms	Colisorb gauze pressure gelatin sponge

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain	VAS visual analogue scale grades (0-10)	7 days

Secondary Outcomes

Measure	Description	Time Frame
closure of the wound	binary method yes or no	15 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

require wisdoms removal

Exclusion Criteria:

systemic diseases affecting healing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 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
Cario University		Cairo	Cairo Governorate	12515	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage
D010146	Pain

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided