NCT07694323

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
19mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 3, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2027

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

June 28, 2026

Last Update Submit

July 7, 2026

Conditions

Peri-implantitis

Keywords

Peri-implantitisPatient-centered outcomesOral health-related quality of lifeDental implantsPatient satisfaction

Outcome Measures

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)

    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 (37)

  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

  • +32 more secondary outcomes

Study Arms (1)

Peri-implantitis

Inclusion Criteria Adult patients (≥18 years old) diagnosed with peri-implantitis according to the definition established by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018). Implants presenting bleeding on probing and/or suppuration, 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 implant's rough surface. In patients requiring multiple surgical interventions, only the first surgical procedure will be included in the study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Octavi Camps

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Links

MeSH Terms

Conditions

Peri-ImplantitisPatient Satisfaction

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Octavi Camps Font, DDS MS PhD

CONTACT

+34 934 024 269ocamps@ub.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 28, 2026

First Posted

July 9, 2026

Study Start (Estimated)

September 3, 2026

Primary Completion (Estimated)

September 3, 2027

Study Completion (Estimated)

March 30, 2028

Last Updated

July 9, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)