Patient Perspectives Throughout Peri-Implantitis Treatment
ConditionPeri-implantitis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Barcelona
About this trial
To evaluate longitudinal changes in oral health-related quality of life (OHRQoL) and other patient-reported outcomes (PROMs) throughout the different stages of peri-implantitis therapy, including diagnosis, non-surgical treatment, surgical treatment, and 6-month follow-up. Secondarily, to explore the influence of clinical, implant-related, and surgical factors on patient-reported outcomes and treatment experience.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years) diagnosed with peri-implantitis according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018).
Implants presenting bleeding on probing (BoP) and/or suppuration on probing (SoP), increased probing depth, and progressive bone loss compared with previous records.
Disqualifiers
Patients who, following non-surgical peri-implantitis treatment, present ≤1 site with isolated bleeding on probing, no suppuration on probing, probing depths ≤5 mm, and no progressive bone loss compared with pretreatment bone levels.
Contraindications to surgical peri-implantitis treatment, including plaque index >20% and bleeding on probing >10%.
Previous radiotherapy to the head and neck region.
Uncontrolled diabetes mellitus/hyperglycaemia (HbA1c >7%).
Trial population
Adults (≥18 years) diagnosed with peri-implantitis according to the 2017 World Workshop classification who require surgical treatment following non-surgical therapy. Participants will be recruited from the Departments of Periodontology at the Hospital Odontològic Universitat de Barcelona (HOUB), the Clínica Universitària d'Odontologia of the Universitat Internacional de Catalunya (CUO-UIC), and the Universitat de València (UV).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
45 Participants
are grouped into 1 trial groupGroup A: Peri-implantitis
Trial outcomes
Primary outcomes
1
Change in Oral Health-Related Quality of Life (OHRQoL)
Change in oral health-related quality of life throughout peri-implantitis treatment, assessed using the Spanish version of the Oral Health Impact Profile-14 (OHIP-14sp). The total OHIP-14sp score ranges from 0 to 56, with higher scores indicating worse oral health-related quality of life. The outcome will be expressed as the total OHIP-14sp score and compared across the four study time points. Unit of Measure: OHIP-14sp total score (0-56)
Time frame
T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment)Secondary outcomes
1
Perceived Pain During Each Stage of Treatment (VAS, 0-100 mm)
Pain perceived by the patient during each stage of peri-implantitis treatment, measured using a 100-mm visual analogue scale (VAS), where 0 indicates no pain and 100 indicates the worst imaginable pain Unit of Measure: Millimeters (0-100 mm VAS)
Time frame
T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).2
Anxiety and Concern Related to Diagnosis and Treatment (VAS, 0-100 mm)
Anxiety and concern perceived by the patient in relation to the diagnosis of peri-implantitis and its treatment, measured using a 100-mm visual analogue scale (VAS), where 0 indicates no anxiety or concern and 100 indicates the highest imaginable level of anxiety or concern. Unit of Measure: Millimeters (0-100 mm VAS)
Time frame
T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).3
Emotional Impact of Peri-Implantitis (VAS, 0-100 mm)
Emotional impact perceived by the patient in relation to the diagnosis of peri-implantitis and its treatment, including feelings such as fear of implant loss and frustration with the diagnosis, measured using a 100-mm visual analogue scale (VAS), where 0 indicates no emotional impact and 100 indicates the highest imaginable emotional impact. Unit of Measure: Millimeters (0-100 mm VAS)
Time frame
T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).4
Satisfaction with Treatment Received (VAS, 0-100 mm)
Patient satisfaction with the treatment received for peri-implantitis, measured using a 100-mm visual analogue scale (VAS), where 0 indicates no satisfaction and 100 indicates the highest possible level of satisfaction. Unit of Measure: Millimeters (0-100 mm VAS)
Time frame
T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Barcelona
Lead sponsor
Universitat Internacional de Catalunya
Collaborator
Universitat de Valencia, España
Collaborator
Source ClinicalTrials.gov
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