NCT05195671

Brief Summary

The ethical review of dental and pharmacy research protocols has its own challenges facing the institutional ethical committees. Seemingly low risk procedure might pose controversies among committees' members. The aim of this article is to describe some of the ethical concerns, particular to dental and pharmacy research that an ethics committee could face while reviewing dental research.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

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

October 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
Last Updated

January 19, 2022

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

December 27, 2021

Last Update Submit

January 13, 2022

Conditions

Review, Research Peer

Keywords

Dental EthicsPharmacy EthicsInstitutional Ethics Committees

Outcome Measures

Primary Outcomes (1)

  • Ethical concerns

    Frequencies and percentages of ethical concerns

    1 month

Interventions

ReviewOTHER

Reviewing all protocols

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All students' research, Post-Grad and Research protocols submitted to MIU Institutional Review Board

You may qualify if:

  • all protocols submitted to IRB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr International University

Cairo, Egypt

Location

Related Publications (14)

  • 1- Allison M. DiMatteo, BA, MP. The Legacy of Dental Research. Inside Dentistry. 2006, June; (2), Issue 5.

    BACKGROUND

  • Gillett GR. Ethics and dental research. J Dent Res. 1994 Nov;73(11):1766-72. doi: 10.1177/00220345940730111401.

    PMID: 7983264BACKGROUND

  • Navabi N, Shahravan A, Modaberi A. Reporting of Ethical Considerations Associated with Clinical Trials Published in Iranian Dental Journals between 2001 and 2011. Iran J Public Health. 2013 Jun 1;42(6):594-601. eCollection 2013.

    PMID: 23967427BACKGROUND

  • Mancl LA, Leroux BG, DeRouen TA. Between-subject and within-subject statistical information in dental research. J Dent Res. 2000 Oct;79(10):1778-81. doi: 10.1177/00220345000790100801.

    PMID: 11077994BACKGROUND

  • Burt BA. Concepts of risk in dental public health. Community Dent Oral Epidemiol. 2005 Aug;33(4):240-7. doi: 10.1111/j.1600-0528.2005.00231.x.

    PMID: 16008630BACKGROUND

  • Naik SP, Nividan KS, Pinto B, Shobha R, Dutt AS, and Rahul N. Ethical Issue and Challenges in Dentistry. International Journal of Preventive and Clinical Dental Research. 2016 October - December; 3(4): 285-87

    BACKGROUND

  • El-Dessouky HF, Abdel-Aziz AM, Ibrahim C, Moni M, Abul Fadl R, Silverman H. Knowledge, Awareness, and Attitudes about Research Ethics among Dental Faculty in the Middle East: A Pilot Study. Int J Dent. 2011;2011:694759. doi: 10.1155/2011/694759. Epub 2011 Jul 3.

    PMID: 21754933BACKGROUND

  • Deolia SG, Prasad K, Chhabra KG, Kalyanpur R, Kalghatgi S. An Insight Into Research Ethics among Dental Professionals in A Dental Institute, India- A Pilot Study. J Clin Diagn Res. 2014 Sep;8(9):ZC11-4. doi: 10.7860/JCDR/2014/10118.4794. Epub 2014 Sep 20.

    PMID: 25386512BACKGROUND

  • Dube-Baril C. The personalized consent form: an optional, but useful tool! J Can Dent Assoc. 2004 Feb;70(2):89-92.

    PMID: 14756938BACKGROUND

  • Fitzgerald DW, Marotte C, Verdier RI, Johnson WD Jr, Pape JW. Comprehension during informed consent in a less-developed country. Lancet. 2002 Oct 26;360(9342):1301-2. doi: 10.1016/S0140-6736(02)11338-9.

    PMID: 12414207BACKGROUND

  • Kadam RA. Informed consent process: A step further towards making it meaningful! Perspect Clin Res. 2017 Jul-Sep;8(3):107-112. doi: 10.4103/picr.PICR_147_16.

    PMID: 28828304BACKGROUND

  • Khallof RO, Doumani M, Farid FAS, Mostafa D, Alhafian RAA. Dental education in the Arabic language vs English language: A survey among Arab dentists. J Family Med Prim Care. 2019 Dec 10;8(12):3908-3914. doi: 10.4103/jfmpc.jfmpc_572_19. eCollection 2019 Dec.

    PMID: 31879634BACKGROUND

  • Hon YK, Narayanan P, Goh PP. Extended discussion of information for informed consent for participation in clinical trials. The Cochrane Database of Systematic Reviews. 2017 (8).

    BACKGROUND

  • Lasers in Dentistry: A Review Chaya M David1, Pankaj Gupta; International Journal of Advanced Health Sciences • Vol 2 Issue 8 • December 2015, 7-13

    BACKGROUND

Related Links

Study Officials

  • Mahassen M Farghaly, Professor

    Vice president of community services and environmental awareness

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2021

First Posted

January 19, 2022

Study Start

October 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 10, 2021

Last Updated

January 19, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)