The Usefulness of Antibiotics in Smokers Receiving Dental Implants

Not Applicable

Completed

• Conditions: Dental Implant Therapy
• Interventions: Procedure: Non-Antibiotic group; Procedure: Antibiotic group

• Registration Number: NCT05827211
• Lead Sponsor: Arab American University (Palestine)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-31
• Study Start: 2023-04-02
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-24
• Primary Completion: 2023-04-30
• Study Completion: 2023-06-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Non-Antibiotic 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.
Test group	Antibiotic 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.

Primary Outcome Measures

Name	Time	Method
Rate of post-operative infection	7 days	signs of infection (fever \> 38 degrees celsius, spontaneous bleeding, pus, swelling, etc.) post-operatively will be checked at suture removal

Trial Locations

Locations (1)

Mahmoud Abu-Ta'a; 🇵🇸 Ramallah, Palestinian Territory, occupied