The Usefulness of Antibiotics in Smokers Receiving Dental Implants

July 19, 2023 updated by: Mahmoud Abu-Ta'a, Arab American University (Palestine)

Asepsis During Periodontal Surgery Involving Oral Implants and the Usefulness of Antibiotics: a Prospective, Randomized, Controlled Clinical Trial

Objectives: This randomized clinical trial will compare the usefulness of pre- and postoperative antibiotics while strict asepsis will be followed during periodontal surgery in smokers diagnosed with Stage III Grade C Generalized Periodontitis.

Material and Methods: Two groups of 40 consecutive patients each with fully or partially edentulous jaws will be enrolled. Antibiotics group (GrAB+): will receive oral doxycycline 200 mg, 1 h pre-operatively and 100 mg g for 9 days post-operatively. Non-antibiotics group (GrAB- ): will receive a placebo (no antibiotics). Bacterial samples will be taken from the peri-oral skin before and at the end of the surgery. In 12 patients in each group, samples will also be taken from the nares. A visual analogue scale will evaluate symptoms of infection/ inflammation by both the patient and the periodontist at suture removal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mahmoud Abu-Ta'a

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • smoker
  • in need of dental implant therapy
  • above 18 years of age

Exclusion Criteria:

  • allergy to doxycycline,
  • need for endocarditis prophylaxis,
  • any systemic or local immunodeficiency,
  • uncontrolled diabetes mellitus,
  • previous radiation therapy in the head and neck area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group
Participants in this group will receive Doxycycline 200 mg 1 h pre-op and 100 mg for 9 days post-op in combination with dental implant therapy.
Procedure: Antibiotic group
Partially or fully edentulous smoker patients will be treated by dental implants and will receive systemic antibiotics
Other Names:
  • Dental implant insertion + Antibiotics
Placebo Comparator: Control group
Participants in this group will receive a placebo 200 mg 1 h pre-op and 100 mg for 9 days post-op in combination with dental implant therapy.
Procedure: Non-Antibiotic group
Partially or fully edentulous smoker patients will be treated by dental implants and will receive placebo
Other Names:
  • Dental implant insertion + Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of post-operative infection
Time Frame: 7 days
signs of infection (fever > 38 degrees celsius, spontaneous bleeding, pus, swelling, etc.) post-operatively will be checked at suture removal
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arab American University (Palestine)

Investigators

  • Principal Investigator: Mahmoud Abu-Ta'a, Department of Dental sciences, Faculty of Graduate Studies, Arab American University (AAUP)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2023

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

June 10, 2023

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Antibiotics

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dental Implant Therapy

Clinical Trials on Antibiotic group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe