NCT06251141

Brief Summary

This research studies the effectiveness of the Gum Health gel in minimizing post operative sequelae associated with the surgical removal of impacted mandibular third molars

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

January 23, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

January 23, 2024

Last Update Submit

February 15, 2024

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (4)

  • Decrease of Pain

    Pain with Visual analog scale

    One week

  • Increase Soft tissue healing

    Soft tissue healing with Early wound healing scale

    One week

  • Decrease in Trismus

    Trismus with Maximum-interincisal- opening (MIO) thatimillimeters

    One week

  • Decrease of Swelling

    Swelling withGrades of swelling

    One week

Study Arms (2)

Study group gum Health gel

ACTIVE COMPARATOR

Study group we fill the sockets with gel foam immersed with Gum Health gel

Procedure: Gum Health gel

Control group gel foam

PLACEBO COMPARATOR

Control group we fill the sockets with gel foam only

Procedure: Gel foam

Interventions

Gum Health gelPROCEDURE

Extraction of impacted mandibular third molars under local anaesthesia and irrigating the socket with normal saline, and filling the socket with the Gum Health gel

Study group gum Health gel
Gel foamPROCEDURE

Extraction of impacted mandibular third molars under local anaesthesia and irrigating the socket

Control group gel foam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Collage of dentistry/ university of baghdad

Baghdad, Iraq

RECRUITING

MeSH Terms

Interventions

Vaginal Creams, Foams, and Jellies

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsFeminine Hygiene ProductsEquipment and Supplies

Central Study Contacts

Ahmed F, Quisi

CONTACT

+9647811896313Ahmedquisi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 9, 2024

Study Start

February 15, 2024

Primary Completion

August 19, 2024

Study Completion

September 19, 2024

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

IR(1)