Peri-implantitisNCT07694323
Patient Perspectives Throughout Peri-Implantitis Treatment
An observational study of Peri-implantitis, run by University of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implantitis
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 3 Sep 2026to 30 Mar 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Octavi Camps
L'Hospitalet de Llobregat, Barcelona, 08907
Octavi Camps Font, DDS MS PhD, +34 934 024 269, ocamps@ub.edu
About this study
Official title: Patient-Centered Outcomes Throughout Peri-Implantitis Therapy: A Multicenter Prospective Observational Study
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.
Read the 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.
- Conditions
- Peri-implantitis
- Keywords
- Peri-implantitis, Patient-centered outcomes, Oral health-related quality of life, Dental implants, Patient satisfaction
- Medical subject headings
- Peri-Implantitis, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Perceived Treatment Outcomes Compared with Expectations (VAS, 0-100 mm)
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)
Measured: T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Perceived Aesthetic Outcome Following Surgical Treatment (VAS, 0-100 mm)
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)
Measured: T2 (6 weeks after surgical treatment) and T3 (6 months after surgical treatment)
Probing Depth (PPD, mm)
Depth of peri-implant sulcus measured at six sites per implant using standardized probing force (20-25 g). Unit of Measure: millimeters (mm)
Measured: T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Radiographic Marginal Bone Level (mm)
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)
Measured: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Peri-Implant Bone Defect Configuration
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)
Measured: T2 (during surgical treatment).
Width of Keratinized Mucosa (KM, mm)
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)
Measured: 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 Keratinized Peri-Implant Mucosa
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])
Measured: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Age
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
Measured: T0 (baseline)
Sex
Self-reported sex of the participant, recorded at baseline. Unit of Measure: Categorical (Male, Female, Other, Prefer not to disclose)
Measured: Time Frame: T0 (baseline)
Smoking Status
Self-reported smoking status at baseline. Unit of Measure: Categorical (Never smoker, Former smoker, Current smoker)
Measured: T0 (baseline)
Cigarettes Smoked per Day
Average number of cigarettes smoked per day, self-reported by current and former smokers.
Unit of Measure: Cigarettes/day
Measured: T0 (baseline)
Relevant Systemic Comorbidities
Presence of relevant systemic comorbidities based on the participant's self-reported medical history and clinical records.
Unit of Measure: Categorical (Yes/No)
Measured: T0 (baseline)
Toothbrushing Frequency
Self-reported frequency of toothbrushing. Unit of Measure: Categorical (Once daily, Twice daily, Three or more times daily)
Measured: T0 (baseline)
Toothbrush Type
Type of toothbrush routinely used by the participant. Unit of Measure: Categorical (Manual, Electric, Both)
Measured: T0 (baseline)
Interproximal Cleaning Method
Primary method used by the participant for interproximal oral hygiene. Unit of Measure: Categorical (Dental floss, Interdental brushes, Oral irrigator, None)
Measured: T0 (baseline)
Frequency of Interproximal Cleaning
Self-reported frequency of interproximal oral hygiene. Unit of Measure: Categorical (Never, Occasionally, Daily)
Measured: T0 (baseline)
Reason for Previous Tooth Loss
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)
Measured: T0 (baseline)
Dental Arch
Arch in which the implant is located. Unit of Measure: Categorical (Maxilla, Mandible)
Measured: T0 (baseline)
Implant Position
Anatomical position of the implant according to its location in the dental arch.
Unit of Measure: Categorical (Anterior, Posterior)
Measured: T0 (baseline)
Specific Implant Site
Specific tooth position replaced by the implant, recorded using the FDI tooth numbering system.
Unit of Measure: Tooth number
Measured: T0 (baseline)
Implant Brand
Commercial brand of the implant. Unit of Measure: Free text
Measured: T0 (baseline)
Implant Model
Commercial model of the implant. Unit of Measure: Free text
Measured: T0 (baseline)
Implant Surface
Type of implant surface according to the manufacturer's specifications. Unit of Measure: Categorical (Treated, Untreated)
Measured: T0 (baseline)
Prosthetic Connection Type
Type of implant-prosthetic connection. Unit of Measure: Categorical (Internal, External, Conical, Other)
Measured: T0 (baseline)
Restoration Retention Type
Type of implant-supported restoration according to its retention mechanism. Unit of Measure: Categorical (Screw-retained, Cement-retained)
Measured: T0 (baseline)
Year of Prosthetic Loading
Calendar year in which the implant-supported prosthetic restoration was delivered and functionally loaded.
Unit of Measure: Year
Measured: T0 (baseline)
Total Number of Implants per Patient
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
Measured: T0 (baseline)
Year of Implant Placement
Calendar year in which the implant was surgically placed. Unit of Measure: Year
Measured: T0 (baseline)
Bleeding and/or Suppuration on Probing (BoP/SoP)
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)
Measured: T0 (immediately after diagnosis), T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Type of Surgical Procedure
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)
Measured: T2 (during surgical treatment)
Postoperative Wound Dehiscence
Presence of postoperative wound dehiscence at the surgical site, assessed during the postoperative clinical examination.
Unit of Measure: Categorical (Present/Absent)
Measured: T2 (6 weeks after surgical treatment)
Postoperative Complications
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)
Measured: T2 (6 weeks after surgical treatment) and T3 (6 months after surgical treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start3 Sep 2026 (estimated)
- Primary completion3 Sep 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Internacional de Catalunya, Universitat de Valencia, España
- Responsible party
- Principal investigator, Octavi Camps-Font, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694323
- Sponsor's protocol ID
- 2025-84-1
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Outcomes Throughout Peri-Implantitis Therapy: A Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07694323
- Acronym / sponsor ID
- 2025-84-1
- Conditions
- Peri-implantitis
- Keywords
- Peri-implantitis, Patient-centered outcomes, Oral health-related quality of life, Dental implants, Patient satisfaction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Collaborators
- Universitat Internacional de Catalunya, Universitat de Valencia, España
- Study start
- 3 Sep 2026 (estimated)
- Primary completion
- 3 Sep 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Oral Health-Related Quality of Life (OHRQoL)
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)
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)
37 secondary outcomes
Perceived Pain During Each Stage of Treatment (VAS, 0-100 mm)
Time frame: 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)
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).
Emotional Impact of Peri-Implantitis (VAS, 0-100 mm)
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).
Satisfaction with Treatment Received (VAS, 0-100 mm)
Time frame: 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)
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).
Perceived Treatment Outcomes Compared with Expectations (VAS, 0-100 mm)
Time frame: T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Perceived Aesthetic Outcome Following Surgical Treatment (VAS, 0-100 mm)
Time frame: T2 (6 weeks after surgical treatment) and T3 (6 months after surgical treatment)
Probing Depth (PPD, mm)
Time frame: T1 (6 weeks after non-surgical treatment), T2 (6 weeks after surgical treatment), and T3 (6 months after surgical treatment).
Radiographic Marginal Bone Level (mm)
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).
Peri-Implant Bone Defect Configuration
Time frame: T2 (during surgical treatment).
Width of Keratinized Mucosa (KM, mm)
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).
Thickness of Keratinized Peri-Implant Mucosa
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).
Age
Time frame: T0 (baseline)
Sex
Time frame: Time Frame: T0 (baseline)
Smoking Status
Time frame: T0 (baseline)
Cigarettes Smoked per Day
Time frame: T0 (baseline)
Relevant Systemic Comorbidities
Time frame: T0 (baseline)
Toothbrushing Frequency
Time frame: T0 (baseline)
Toothbrush Type
Time frame: T0 (baseline)
Interproximal Cleaning Method
Time frame: T0 (baseline)
Frequency of Interproximal Cleaning
Time frame: T0 (baseline)
Reason for Previous Tooth Loss
Time frame: T0 (baseline)
Dental Arch
Time frame: T0 (baseline)
Implant Position
Time frame: T0 (baseline)
Specific Implant Site
Time frame: T0 (baseline)
Implant Brand
Time frame: T0 (baseline)
Implant Model
Time frame: T0 (baseline)
Implant Surface
Time frame: T0 (baseline)
Prosthetic Connection Type
Time frame: T0 (baseline)
Restoration Retention Type
Time frame: T0 (baseline)
Year of Prosthetic Loading
Time frame: T0 (baseline)
Total Number of Implants per Patient
Time frame: T0 (baseline)
Year of Implant Placement
Time frame: T0 (baseline)
Bleeding and/or Suppuration on Probing (BoP/SoP)
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).
Type of Surgical Procedure
Time frame: T2 (during surgical treatment)
Postoperative Wound Dehiscence
Time frame: T2 (6 weeks after surgical treatment)
Postoperative Complications
Time frame: T2 (6 weeks after surgical treatment) and T3 (6 months after surgical treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Hospital Odontològic Universitat de BarcelonaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-implantitis, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Octavi Camps Font, DDS MS PhD (+34 934 024 269, ocamps@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oral Health-Related Quality of Life (OHRQoL) (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.