Home » Trials » SLCTR/2025/031
A Randomized Clinical Trial Comparing the Efficacy of Preoperative vs. Postoperative Antibiotic Regimens in Single Straightforward Dental Implant Procedures
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SLCTR Registration Number
SLCTR/2025/031
Date of Registration
The date of last modification
Aug 21, 2025
Scientific Title of Trial
A Randomized Clinical Trial Comparing the Efficacy of Preoperative vs. Postoperative Antibiotic Regimens in Single Straightforward Dental Implant Procedures
Public Title of Trial
A Randomized Clinical Trial Comparing the Efficacy of Preoperative vs. Postoperative Antibiotic Regimens in Single Straightforward Dental Implant Procedures.
Disease or Health Condition(s) Studied
Dental implants, antibiotic prophylaxis.
Scientific Acronym
None
Public Acronym
None
Brief title
Time of antibiotic administration in single straightforward implants.
Universal Trial Number
U1111-1321-5243
Any other number(s) assigned to the trial and issuing authority
ODC-2024-AS-206 - Ethics, Research & Innovation Committee (ERIC), Oman Dental College, Muscat, Oman
What is the research question being addressed?
In single straightforward dental implant procedures, does preoperative antibiotic administration reduce postoperative pain and inflammation more effectively than postoperative administration?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Healthcare providers, Outcome assessors
Control
Dose comparison
Assignment
Parallel
Purpose
Prevention
Study Phase
Phase 4
Intervention(s) planned
Study setting: Department of Oral Surgery at Oman Dental College, located in Muscat, Oman. Patients planned for single straightforward implants will be recruited from the outpatient clinic of the Department of Oral Surgery.
Simple randomization will be performed using a computer- generated random number list. Each participant is assigned a number in sequence, and based on that number, allocated to either the preoperative or postoperative
It is a two arm study, where two interventions are being studied. Pre-operative antibiotics versus post- operative antibiotics.
In the pre-operative regimen, a single dose of 2 grams of amoxicillin is used.
In the post-operative regimen, 500mg capsules of amoxicillin is used three times a day for 5 days. All doses are administered orally.
Inclusion criteria
Age above 18
Both male and female
Single straightforward implants. - Patients scheduled to undergo single straightforward implants at the oral Surgery Department in Oman Dental College.
Patients must possess the ability to self-administer the questionnaire. This includes having the literacy and comprehension skills necessary to understand and respond accurately to the modified validated Arabic version of the Post-operative symptoms following implant surgery Questionnaire.
Exclusion criteria
• Patients who require multiple dental implant surgery. • Patients who require multiple adjacent implant surgeries. • Patients who require soft or/and hard tissue augmentation. • Patients who require pre-prosthetic surgery. • Patients who require immediate implant surgery. • Individuals with cognitive impairments that impede their ability to understand the consent process or to accurately fill out the questionnaires.
Primary outcome(s)
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1.
Pain and swelling using visual analogue scale: a modified validated Arabic version, consisting of 15 questions across 2 sections: The score ranges from 0 to 5, with lower scores indicating better outcomes. |
[ post surgery for 5 days ] |
|
2.
Two-weeks Post-Operative Healing Assessment for Dental Implants: an assessment collected 2 weeks after the implant surgery by one investigator before the suture removal, evaluating soft tissue status and overall healing assessment based on inflammation, erythema, and pus formation |
[ two weeks after surgery ] |
|
3.
Two-Month Post-Operative Healing Assessment for Dental Implants: an assessment collected 2 months after the implant surgery by one investigator before the implant crown impression. Evaluating the following points: soft tissue status, hard tissue status, radiographical assessment & overall healing assessment. |
[ two months after surgery ] |
Secondary outcome(s)
|
1.
None |
[] |
Target number/sample size
30 ( 15 each)
Countries of recruitment
Oman
Anticipated start date
2025-09-01
Anticipated end date
2026-08-31
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Ethics, Research & Innovation Committee (ERIC), Oman Dental College, Muscat, Oman
Status
Approved
Date of Approval
2024-12-04
Approval number
ODC-2024-AS-206
Details of Ethics Review Committee
| Name: | Ethics, Research & Innovation Committee (ERIC), Oman Dental College, Muscat, Oman |
| Institutional Address: | Oman Dental College PO Box 835, Mina Al Fahal, Postal Code 116 Sultanate of Oman |
| Telephone: | 0096824665555 |
| Email: | research@staff.odc.edu.om |
Contact person for Scientific Queries/Principal Investigator
Mayar Ghaith
Dental Student
Oman Dental College PO Box 835, Mina Al Fahal, Postal Code 116 Sultanate of Oman
96897647585
mayarghaithradi@gmail.com
Contact Person for Public Queries
Amur Al Senaidi
Assistant Professor
Oman Dental College PO Box 835, Mina Al Fahal, Postal Code 116 Sultanate of Oman
96894388846
aalsenaidi@staff.odc.edu.om
Primary study sponsor/organization
Abubaker Edin Qutieshat
Research Head
Oman Dental College PO Box 835, Mina Al Fahal, Postal Code 116 Sultanate of Oman
479151504
research@staff.odc.edu.om
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
