Peri-implantitis
Conditions
Keywords
Peri-implantitis, Patient-centered outcomes, Oral health-related quality of life, Dental implants, Patient satisfaction
Brief summary
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.
Detailed description
Prospective multicenter observational cohort study conducted at three university centers: the University of Barcelona (coordinating center), the International University of Catalonia, and the University of Valencia. Patients diagnosed with peri-implantitis and requiring surgical treatment will be consecutively recruited and followed through four evaluation time points: T0: Diagnosis T1: Six weeks after non-surgical therapy T2: Six weeks after surgical treatment T3: Six-month follow-up Primary objective: To evaluate longitudinal changes in oral health-related quality of life (OHRQoL) throughout peri-implantitis therapy. OHRQoL will be assessed using a modified version of the OHIP-14 questionnaire specifically adapted for patients with peri-implantitis. Secondary objectives: To assess changes in patient-reported experience measures (PREMs), including pain, anxiety, emotional impact, satisfaction, functional limitations, aesthetic perception, and treatment expectations. To investigate the association between patient-reported outcomes and clinical parameters such as probing depth, bleeding/suppuration on probing, peri-implant bone loss, tissue phenotype, and defect morphology. To evaluate whether patient-reported outcomes differ according to the type of surgical treatment performed (access, resective, regenerative, or combined surgery). To explore the influence of patient-, implant-, and prosthetic-related factors on treatment experience and quality of life outcomes. At each study visit, participants will complete the patient-reported outcome questionnaire and undergo standardized clinical assessments. The study does not modify routine clinical care, and all treatments will be provided according to current clinical guidelines and clinician judgment. This study aims to provide novel evidence regarding the real-world patient experience throughout peri-implantitis therapy and to support a more patient-centered approach to peri-implant disease management.
Interventions
None listed
Sponsors
University of Barcelona
Universitat Internacional de Catalunya
Universitat de Valencia, España
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. When previous records are unavailable, implants will be included if they present bleeding and/or suppuration on gentle probing, probing depth ≥6 mm, and a bone level ≥3 mm apical to the most coronal portion of the rough implant surface. \- For patients requiring multiple peri-implantitis surgeries, only the first surgical intervention will be included.
Exclusion criteria
* 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%). * Pregnancy or breastfeeding at the time of enrollment. * Alcohol or substance abuse. * Previous surgical treatment of peri-implantitis at the same implant. * Inability to complete the postoperative pain assessment (VAS) or the oral health-related quality of life (OHRQoL) questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oral Health-Related Quality of Life (OHRQoL) | T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Pain During Each Stage of Treatment (VAS, 0-100 mm) | T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment). | 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) |
| Anxiety and Concern Related to Diagnosis and Treatment (VAS, 0-100 mm) | T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment). | 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) |
| Emotional Impact of Peri-Implantitis (VAS, 0-100 mm) | T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment). | 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) |
| Satisfaction with Treatment Received (VAS, 0-100 mm) | T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment). | 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) |
| Perceived Oral Function (VAS, 0-100 mm) | T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment). | Patient-perceived oral function following peri-implantitis treatment, including the ability to chew, speak, and perform oral hygiene, measured using a 100-mm visual analogue scale (VAS), where 0 indicates complete functional impairment and 100 indicates normal oral function. Unit of Measure: Millimeters (0-100 mm VAS) |
| Perceived Treatment Outcomes Compared with Expectations (VAS, 0-100 mm) | T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment). | Patient perception of the extent to which the outcomes of peri-implantitis treatment met their initial expectations, measured using a 100-mm visual analogue scale (VAS), where 0 indicates that the treatment outcomes did not meet expectations at all and 100 indicates that the treatment outcomes completely met or exceeded expectations. Unit of Measure: Millimeters (0-100 mm VAS) |
| Perceived Aesthetic Outcome Following Surgical Treatment (VAS, 0-100 mm) | T2 (6 weeks after surgical treatment) and T3 (6 months after surgical treatment) | Patient perception of the aesthetic outcome following surgical treatment for peri-implantitis, measured using a 100-mm visual analogue scale (VAS), where 0 indicates complete dissatisfaction with the aesthetic outcome and 100 indicates complete satisfaction with the aesthetic outcome. Unit of Measure: Millimeters (0-100 mm VAS) |
| Probing Depth (PPD, mm) | T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment). | Depth of peri-implant sulcus measured at six sites per implant using standardized probing force (20-25 g). Unit of Measure: millimeters (mm) |
| Radiographic Marginal Bone Level (mm) | T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment). | Radiographic marginal bone level measured in millimeters as the distance from the implant reference point designed to be in intimate contact with the bone to the most coronal bone-to-implant contact on standardized periapical radiographs. Unit of Measure: Millimeters (mm) |
| Peri-Implant Bone Defect Configuration | T2 (during surgical treatment). | Peri-implant bone defect morphology classified according to the predominant defect configuration as intrabony, suprabony, or combined, based on the intraoperative clinical assessment. Unit of Measure: Categorical (intrabony, suprabony, combined) |
| Width of Keratinized Mucosa (KM, mm) | T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment). | Distance from the mucosal margin to the mucogingival junction at the buccal aspect of the implant, measured using a periodontal probe. Unit of Measure: Millimeters (mm) |
| Thickness of Keratinized Peri-Implant Mucosa | T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment). | Thickness of the buccal keratinized peri-implant mucosa assessed using the periodontal probe transparency method. The mucosa is classified as thin if the periodontal probe is visible through the tissue (\<1 mm) and thick if the probe is not visible (≥1 mm). Unit of Measure: Categorical (thin \[\<1 mm\] or thick \[≥1 mm\]) |
| Age | T0 (baseline) | Participant age at baseline (T0), calculated as the interval between the date of birth and the enrollment date. Unit of Measure: Years, months, and days |
| Sex | Time Frame: T0 (baseline) | Self-reported sex of the participant, recorded at baseline. Unit of Measure: Categorical (Male, Female, Other, Prefer not to disclose) |
| Smoking Status | T0 (baseline) | Self-reported smoking status at baseline. Unit of Measure: Categorical (Never smoker, Former smoker, Current smoker) |
| Cigarettes Smoked per Day | T0 (baseline) | Average number of cigarettes smoked per day, self-reported by current and former smokers. Unit of Measure: Cigarettes/day |
| Relevant Systemic Comorbidities | T0 (baseline) | Presence of relevant systemic comorbidities based on the participant's self-reported medical history and clinical records. Unit of Measure: Categorical (Yes/No) |
| Toothbrushing Frequency | T0 (baseline) | Self-reported frequency of toothbrushing. Unit of Measure: Categorical (Once daily, Twice daily, Three or more times daily) |
| Toothbrush Type | T0 (baseline) | Type of toothbrush routinely used by the participant. Unit of Measure: Categorical (Manual, Electric, Both) |
| Interproximal Cleaning Method | T0 (baseline) | Primary method used by the participant for interproximal oral hygiene. Unit of Measure: Categorical (Dental floss, Interdental brushes, Oral irrigator, None) |
| Frequency of Interproximal Cleaning | T0 (baseline) | Self-reported frequency of interproximal oral hygiene. Unit of Measure: Categorical (Never, Occasionally, Daily) |
| Reason for Previous Tooth Loss | T0 (baseline) | Primary reason for the loss of the tooth replaced by the implant, based on the participant's dental history and clinical records. Unit of Measure: Categorical (Periodontitis, Caries, Endodontic failure, Root fracture, Trauma, Congenital absence, Orthodontic extraction, Other) |
| Dental Arch | T0 (baseline) | Arch in which the implant is located. Unit of Measure: Categorical (Maxilla, Mandible) |
| Implant Position | T0 (baseline) | Anatomical position of the implant according to its location in the dental arch. Unit of Measure: Categorical (Anterior, Posterior) |
| Specific Implant Site | T0 (baseline) | Specific tooth position replaced by the implant, recorded using the FDI tooth numbering system. Unit of Measure: Tooth number |
| Implant Brand | T0 (baseline) | Commercial brand of the implant. Unit of Measure: Free text |
| Implant Model | T0 (baseline) | Commercial model of the implant. Unit of Measure: Free text |
| Implant Surface | T0 (baseline) | Type of implant surface according to the manufacturer's specifications. Unit of Measure: Categorical (Treated, Untreated) |
| Prosthetic Connection Type | T0 (baseline) | Type of implant-prosthetic connection. Unit of Measure: Categorical (Internal, External, Conical, Other) |
| Restoration Retention Type | T0 (baseline) | Type of implant-supported restoration according to its retention mechanism. Unit of Measure: Categorical (Screw-retained, Cement-retained) |
| Year of Prosthetic Loading | T0 (baseline) | Calendar year in which the implant-supported prosthetic restoration was delivered and functionally loaded. Unit of Measure: Year |
| Total Number of Implants per Patient | T0 (baseline) | Total number of dental implants present in the participant at baseline, recorded to account for patient-level clustering in statistical analyses. Unit of Measure: Number of implants |
| Year of Implant Placement | T0 (baseline) | Calendar year in which the implant was surgically placed. Unit of Measure: Year |
| Bleeding and/or Suppuration on Probing (BoP/SoP) | T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment). | Presence of bleeding and/or suppuration elicited within 30 seconds after gentle probing at six sites per implant using a standardized periodontal probe. Unit of Measure: Categorical (Present/Absent) |
| Type of Surgical Procedure | T2 (during surgical treatment) | Surgical approach used for the treatment of peri-implantitis, classified according to the primary surgical technique performed. Unit of Measure: Categorical (Access surgery, Resective surgery, Regenerative surgery, Combined surgery) |
| Postoperative Wound Dehiscence | T2 (6 weeks after surgical treatment) | Presence of postoperative wound dehiscence at the surgical site, assessed during the postoperative clinical examination. Unit of Measure: Categorical (Present/Absent) |
| Postoperative Complications | T2 (6 weeks after surgical treatment) and T3 (6 months after surgical treatment) | Occurrence of postoperative complications related to peri-implantitis surgery, including the type of complication when present. Unit of Measure: Categorical (Absent/Present) and free text (type of complication) |
Countries
Spain
Contacts
CONTACTOctavi Camps Font, DDS MS PhD
Outcome results
None listed