The Usefulness of Antibiotics in Smokers Receiving Dental Implants

NCT05827211 | Completed

• 1 other identifier: Antibiotics
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Rate of post-operative infection

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

  7 days

Study Arms (2)

Test group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Antibiotic group PROCEDURE

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

Also known as: Dental implant insertion + Antibiotics

Test group

Non-Antibiotic group PROCEDURE

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

Also known as: Dental implant insertion + Placebo

Control group

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Arab American University (Palestine): lead

Study Sites (1)

Mahmoud Abu-Ta'a

Ramallah, Palestinian Territories

Location

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Mahmoud Abu-Ta'a

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 24, 2023
• Study Start: April 2, 2023
• Primary Completion: April 30, 2023
• Study Completion: June 10, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

PA (1)