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The Usefulness of Antibiotics in Smokers Receiving Dental Implants

Sponsor
Arab American University (Palestine) (Other)
Overall Status
Recruiting
CT.gov ID
NCT05827211
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
1.2
Anticipated Duration (Months)
64.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Antibiotic group
  • Procedure: Non-Antibiotic group
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Asepsis During Periodontal Surgery Involving Oral Implants and the Usefulness of Antibiotics: a Prospective, Randomized, Controlled Clinical Trial
Actual Study Start Date :
Apr 2, 2023
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
May 10, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Signs of post-operative infection [7 days]

      signs of infection (fever > 38degrees celsius, spontaneous bleeding, pus, swelling, etc.) post-operatively will be checked at suture removal

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mahmoud Abu-Ta'a Ramallah Palestinian Territory, occupied

    Sponsors and Collaborators

    • Arab American University (Palestine)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahmoud Abu-Ta'a, Associate Professor, Arab American University (Palestine)
    ClinicalTrials.gov Identifier:
    NCT05827211
    Other Study ID Numbers:
    • Antibiotics
    First Posted:
    Apr 24, 2023
    Last Update Posted:
    Apr 24, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anti-Bacterial Agents
    Antibiotics, Antitubercular

    Study Results

    No Results Posted as of Apr 24, 2023