NCT07638930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2022

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

Same day

First QC Date

June 5, 2026

Last Update Submit

June 9, 2026

Conditions

BleedingPain

Keywords

gelatin spongesurgical tooth extraction;hemostasispainrandomized clinical trial.

Outcome Measures

Primary Outcomes (1)

  • pain

    VAS visual analogue scale grades (0-10)

    7 days

Secondary Outcomes (1)

  • closure of the wound

    15 days

Study Arms (3)

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

wisdoms' surgical extractionsPROCEDURE

surgical removal of wisdoms

Colisorbgauze pressuregelatin sponge

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • require wisdoms removal

You may not qualify if:

  • systemic diseases affecting healing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cario University

Cairo, Cairo Governorate, 12515, Egypt

Location

MeSH Terms

Conditions

HemorrhagePain

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3 arm clinical trail
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 10, 2026

Study Start

May 26, 2022

Primary Completion

May 26, 2022

Study Completion

May 26, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Locations

EG(1)