Timing of Success Evaluation After Flapless Treatment of Peri-Implantitis
ConditionPeri-implantitis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Barcelona
About this trial
Peri-implantitis is an inflammatory disease around dental implants that causes progressive loss of the bone supporting the implant. Current clinical guidelines recommend treating it first with a non-surgical approach and then checking treatment success, usually between 6 and 12 weeks later. However, it is not known whether this is the best time to check the results, since no previous studies have compared different follow-up time points.
This study will follow patients with peri-implantitis who receive the same non-surgical, flapless treatment. Their implants will be checked at five different times after treatment (6 and 12 weeks, and 6, 9, and 12 months) to see how the clinical outcome changes over time. The main goal is to find out how treatment success evolves at these different time points, and whether the results seen early (at 6 weeks) match the final results seen at 12 months
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years or older.
General health status compatible with dental treatment (ASA I-II).
Ability to understand the study, sign the informed consent form, and comply with the follow-up protocol.
Presence of one or more dental implants in function for at least 12 months, placed at any center, regardless of connection type or the presence of platform switching.
Disqualifiers
Refusal to participate in the study or inability to provide informed consent.
Non-acceptance of the proposed treatment.
Pregnancy or breastfeeding.
Treatment with drugs or presence of diseases that may alter the healing of peri-implant tissues or interfere with the response to treatment (e.g., immunosuppressants, systemic corticosteroids at immunosuppressive doses, or treatment with antiresorptive or antiangiogenic agents).
Trial population
Adult patients with at least one dental implant in function for at least 12 months, diagnosed with peri-implantitis according to the 2017 World Workshop criteria, treated at the Hospital Odontològic Universitat de Barcelona.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Flapless non-surgical treatment of peri-implantitis
Procedure/SurgeryNon-surgical flapless treatment consisting of oral hygiene motivation and instructions, removal of the implant-supported prosthesis when possible, modification of the emergence profile when indicated, supra- and submucosal mechanical debridement using ultrasonic devices with periodontal tips and steel curettes, removal of granulation tissue, and curettage of the peri-implant mucosa. Followed by chlorhexidine gel twice daily for 15 days and systemic antibiotic therapy (metronidazole 500 mg three times daily for 7 days, or azithromycin 500 mg once daily for 3 days in case of allergy/contraindication)
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Flapless treatment1 intervention
Trial outcomes
Primary outcomes
1
Clinical Success Following Flapless Treatment of Peri-Implantitis
Clinical success, recorded dichotomously (success/no success), assessed at six sites per implant. An implant is classified as a clinical success when probing depth (PD) is ≤5 mm at all six sites, bleeding on probing is present at, at most, one site and presents as an isolated spot rather than a line or profuse bleeding, and suppuration is absent at all sites.
Time frame
6 weeks, 12 weeks, 6 months, 9 months, and 12 months after treatmentSecondary outcomes
1
Age (Years)
Age at inclusion, recorded in completed years.
Time frame
Baseline (T0)2
Sex (Male/Female)
Sex of participants.
Time frame
Baseline (T0)3
Smoking Status (Never Smoker/Former Smoker/Current Smoker)
Smoking status classified as never smoker, former smoker, or current smoker. In current and former smokers, cumulative smoking exposure will be recorded in pack-years; in current smokers, daily cigarette consumption will also be recorded.
Time frame
Baseline (T0)4
Periodontal Diagnosis (Stage I-IV; Grade A-C)
Periodontal diagnosis according to the classification of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
Time frame
Baseline (T0)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: