The Usefulness of Antibiotics in Smokers Receiving Dental Implants

NCT ID: NCT05827211

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-02
• Study Completion Date: 2023-06-10

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.

Conditions

Dental Implant Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Antibiotic group

Intervention Type: PROCEDURE

Partially or fully edentulous smoker patients will be treated by dental implants and will receive systemic antibiotics

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.

Group Type: PLACEBO_COMPARATOR

Non-Antibiotic group

Intervention Type: PROCEDURE

Partially or fully edentulous smoker patients will be treated by dental implants and will receive placebo

Interventions

Antibiotic group

Partially or fully edentulous smoker patients will be treated by dental implants and will receive systemic antibiotics

Intervention Type: PROCEDURE

Non-Antibiotic group

Partially or fully edentulous smoker patients will be treated by dental implants and will receive placebo

Intervention Type: PROCEDURE

Other Intervention Names

Dental implant insertion + Antibiotics; Dental implant insertion + Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arab American University (Palestine)

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Abu-Ta'a

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud Abu-Ta'a

Role: PRINCIPAL_INVESTIGATOR

Department of Dental sciences, Faculty of Graduate Studies, Arab American University (AAUP)

Locations

Mahmoud Abu-Ta'a

Ramallah, , Palestinian Territories

Countries

Palestinian Territories

Other Identifiers

Antibiotics

Identifier Type: -

Identifier Source: org_study_id