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NCT Number: NCT05827211

The Usefulness of Antibiotics in Smokers Receiving Dental Implants

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.

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Key information

Conditions

Dental Implant Therapy

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahmoud Abu-Ta'a

Ramallah, Palestinian Territories

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic group

Procedure

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

Other names: Dental implant insertion + Antibiotics

Non-Antibiotic group

Procedure

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

Other names: Dental implant insertion + Placebo

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Arab American University (Palestine)

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2023
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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