NCT05944939

Brief Summary

Preoperative radiograph will be taken to assess the type of impaction either mesioangular, horizontal, distoangular and check mouth opening. Two groups involve in my study. After taking consent from all patients in first group is control group open extraction of impacted mandibular third molar prepared concentrated growth factor placed in fresh socket closure done with silk 3.0. In second case group open extraction of impacted mandibular third molar is closure with silk 3.0 without placement of concentrated growth factor. Bone density will assessed using cone beam computed tomography 3 month and 6month postoperatively.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

2 active sites

Status
unknown

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 4, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2023

Completed
Last Updated

August 3, 2023

Status Verified

October 1, 2022

Enrollment Period

1 month

First QC Date

May 30, 2023

Last Update Submit

August 1, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measure of bone density with help of cone beam computerized tomography after 3 months and 6 months

    Cases compare with control with help of cone beam computerized tomography

    3 month and 6 month

Study Arms (2)

Case group

EXPERIMENTAL

After third molar extraction concentrated growth factor is palced in socket and closure with silk3.0 compare bone density with control group

Procedure: Surgical extraction of impacted third molar

Control group

EXPERIMENTAL

After extraction closure with silk 3.0 compare bone density with cases

Procedure: Surgical extraction of impacted third molar

Interventions

After surgical extraction of mandibular impacted teeth concentrated growth factor placed in socket closure done with help of silk 3.0 suture

Case groupControl group

Eligibility Criteria

Age17 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Both genders
  • Age above 17 years
  • Impacted mandibular third molar

You may not qualify if:

  • Teeth require closed extraction
  • Significant medical history ( e.g. uncontrolled diabetes mellitus )
  • Patients with history of radiotherapy and chemotherapy
  • Bleeding disorders
  • Any pathology like tumor and cyst 6. Developmental disorder 7. Previously operated any surgery of jaw 8. cigarette smokers 9. Maxillary third molar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dow Dental college Dow university of health sciences

Karachi, Sindh, Pakistan

Location

Dow university of health sciences

Karachi, Sindh, Pakistan

Location

Study Officials

  • D O W

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2023

First Posted

July 14, 2023

Study Start

May 4, 2022

Primary Completion

June 6, 2022

Study Completion

December 6, 2023

Last Updated

August 3, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Randmised control trial

Shared Documents
ICF
Time Frame
6 month
Access Criteria
Bone density with cbct

Locations