Peri-implantitisNCT07557459
Access to Probing and Peri-implant Diseases
An observational study of Peri-implantitis and Peri-implant Bone Loss, run by Arrow Development at 9 sites in Spain.
Trial summary
This multicenter cross-sectional study aims to evaluate the association between access to peri-implant probing and radiographic peri-implant bone loss. Although probing is the primary diagnostic tool for peri-implant diseases, prosthetic design may limit access, potentially affecting diagnosis and disease progression. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peri-implantitis, Peri-implant Bone Loss
- What is being tested?
- Peri-implant probing
- How many people
- 281 participants
- Where
- 9 sitesSpain
- Study dates
- 1 Sep 2026to Dec 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients attending participating clinics for the first time for maintenance, review, or treatment, with dental implants in function for at least three years
Who may be able to join
- Age ≥18 years
- Dental implants loaded for at least 3 years
- Implant-supported restorations (single, partial fixed, or full-arch)
- First visit to the clinic (maintenance, review, or treatment)
- Signed informed consent
- Availability of clinical and radiographic records
Who cannot join
- Exposure of the intraosseous portion of the implant
- Evident prosthetic misfit
- Inability to provide informed consent
- Lack of cooperation for clinical examination
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Spain9 sites, 9 recruiting
- Recruiting
Clínica Barbieri
A Coruña, A Coruña, 15004
Germán Barbieri, +34881925209, arrow@archealth.eu
- Recruiting
Clínica Ortiz-Vigón
Bilbao, Vizcaya, 48008
Alberto Ortiz-Vigón, +34944158902, arrow@archealth.eu
- Recruiting
PerioCentrum Guadalajara
Guadalajara, Guadalajara, 10991
Daniel Rodrigo, +34949223799, arrow@archealth.eu
- Recruiting
Clínica Bio
Madrid, Madrid, 28001
Eva Rosa, +34917812700, arrow@archealth.eu
- Recruiting
Centro de Periodoncia e Implantes Aranda-Macera
Madrid, Madrid, 28007
Juanjo Aranda, +34915296437, arrow@archealth.eu
- Recruiting
Madrid Perio & Implant Clinic
Madrid, Madrid, 28007
Pedro Lázaro, +34914340258, arrow@archealth.eu
- Recruiting
Salud y Estética Dental SCH Zurbano S.L.
Madrid, Madrid, 28010
Nerea Sánchez, +34912774222, arrow@archealth.eu
- Recruiting
Clínica Dental NEXUS
Málaga, Málaga, 29008
Gustavo Cabello, +34952060758, arrow@archealth.eu
- Recruiting
Clínica Sánchez Cortés
Pozuelo de Alarcón, Madrid, 28224
María Rioboo, +34913522257, arrow@archealth.eu
About this study
Official title: Access to Peri-implant Probing and Its Association With Peri-implant Diseases: A Multicenter Cross-Sectional Study
This multicenter cross-sectional study aims to evaluate the association between access to peri-implant probing and radiographic peri-implant bone loss. Although probing is the primary diagnostic tool for peri-implant diseases, prosthetic design may limit access, potentially affecting diagnosis and disease progression. The study will include patients with dental implants in function for at least three years and will assess clinical, radiographic, and prosthetic variables.
Read the detailed description
Peri-implantitis is a plaque-induced inflammatory condition characterized by inflammation of peri-implant tissues and progressive bone loss. Probing is essential for diagnosis; however, prosthetic design may hinder or prevent proper probing access, potentially compromising diagnostic accuracy.
Despite its clinical relevance, no studies have directly evaluated whether limited access to probing is associated with peri-implant bone loss. This study aims to address this gap.
This is a multicenter cross-sectional observational study conducted in nine private clinics in Spain. A total of 281 patients will be included. Clinical and radiographic data will be collected, including probing accessibility, probing depth, plaque index, bleeding on probing, suppuration, prosthetic design, hygiene accessibility, and radiographic bone levels.
Statistical analysis will evaluate associations between probing access and peri-implant bone loss at both patient and implant levels.
- Conditions
- Peri-implantitis, Peri-implant Bone Loss
- Being tested
- Peri-implant probing
- Keywords
- Peri-implantitis, Dental Implants, Probing, Bone Loss, Prosthetic Design, Oral Hygiene, Cross-sectional Study
- Medical subject headings
- Peri-Implantitis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-implant probingDiagnostic test
This is a non-interventional, observational cross-sectional multicenter study. No therapeutic, surgical, or pharmacological interventions are performed as part of the study.
All procedures correspond to standard clinical practice and include:
Peri-implant clinical examination, consisting of probing depth measurements at six sites per implant using a manual periodontal probe. When access is limited, a flexible plastic probe may be used.
Assessment of probing accessibility, categorized according to the angulation and feasibility of probe insertion without prosthesis removal (possible, limited, or impossible).
Recording of routine clinical parameters, including plaque presence, bleeding on probing, suppuration, and patient-reported hygiene practices.
Radiographic assessment, consisting of standardized periapical radiographs obtained using a parallel technique for the evaluation of marginal bone levels.
No modifications to the patients' treatment, prosthetic design, or maintenance protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between probing access and peri-implant radiographic bone loss
Evaluation of whether limited or impossible probing access is associated with increased radiographic bone loss (measured in mm from implant platform to bone level).
Measured: Baseline (cross-sectional assessment)
Secondary outcomes (5)
Prevalence of implants with limited or no probing accessibility
Proportion of implants classified as having limited or impossible access to peri-implant probing, based on probe angulation and feasibility without prosthesis removal.
Measured: Assessed at the baseline visit (single cross-sectional evaluation)
Prevalence of non-hygienizable implant-supported prostheses
Proportion of implant-supported restorations classified as non-hygienizable, defined as the inability to pass an interdental brush of at least 0.4 mm diameter
Measured: Assessed at the baseline visit (single cross-sectional evaluation)
Association between hygiene accessibility and peri-implant bone loss
Evaluation of the relationship between prosthetic hygiene accessibility (hygienizable vs non-hygienizable) and radiographic peri-implant marginal bone levels.
Measured: Assessed at the baseline visit (single cross-sectional evaluation)
Clinical peri-implant parameters
Assessment of peri-implant clinical parameters, including plaque presence, bleeding on probing, suppuration, and probing depth (when measurable), in relation to probing accessibility.
Measured: Assessed at the baseline visit (single cross-sectional evaluation)
Patient-related and implant-related factors associated with probing accessibility
Exploratory analysis of the association between probing accessibility and variables such as type of prosthesis (single, partial, full-arch), implant characteristics (bone level/tissue level, connection type), and patient-related factors (oral hygiene habits, maintenance frequency, history of periodontitis).
Measured: Assessed at the baseline visit (single cross-sectional evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Sep 2026
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 281 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arrow Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinica Dental Nexus, Malaga, Salud y Estetica Dental SCH Zurbano S.L, Clinica Bio, Madrid, Centro de Periodoncia e Implantes Aranda-Macera, Madrid, Clínica Sánchez Cortés, Madrid, Madrid Perio & Implant Clinic, Madrid, Clínica Barbieri, A Coruña, Clinica Ortiz-Vigon, Bilbao, PerioCentrum Guadalajara
- Responsible party
- Principal investigator, Alberto Ortiz Vigon, Arrow Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557459
- Sponsor's protocol ID
- 01924
- Status last verified
- Oct 2026
- First submitted
- 23 Apr 2026
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access to Peri-implant Probing and Its Association With Peri-implant Diseases: A Multicenter Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07557459
- Acronym / sponsor ID
- 01924
- Conditions
- Peri-implantitis, Peri-implant Bone Loss
- Keywords
- Peri-implantitis, Dental Implants, Probing, Bone Loss, Prosthetic Design, Oral Hygiene, Cross-sectional Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 281 participants (estimated)
- Lead sponsor
- Arrow DevelopmentIndustry (pharma, biotech, devices)
- Collaborators
- Clinica Dental Nexus, Malaga, Salud y Estetica Dental SCH Zurbano S.L, Clinica Bio, Madrid, Centro de Periodoncia e Implantes Aranda-Macera, Madrid, Clínica Sánchez Cortés, Madrid, Madrid Perio & Implant Clinic, Madrid, Clínica Barbieri, A Coruña, Clinica Ortiz-Vigon, Bilbao, PerioCentrum Guadalajara
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Apr 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.
This multicenter cross-sectional study aims to evaluate the association between access to peri-implant probing and radiographic peri-implant bone loss. Although probing is the primary diagnostic tool for peri-implant diseases, prosthetic design may limit access, potentially affecting diagnosis and disease progression. The study will include patients with dental implants in function for at least three years and will assess clinical, radiographic, and prosthetic variables.
Detailed description
Peri-implantitis is a plaque-induced inflammatory condition characterized by inflammation of peri-implant tissues and progressive bone loss. Probing is essential for diagnosis; however, prosthetic design may hinder or prevent proper probing access, potentially compromising diagnostic accuracy.
Despite its clinical relevance, no studies have directly evaluated whether limited access to probing is associated with peri-implant bone loss. This study aims to address this gap.
This is a multicenter cross-sectional observational study conducted in nine private clinics in Spain. A total of 281 patients will be included. Clinical and radiographic data will be collected, including probing accessibility, probing depth, plaque index, bleeding on probing, suppuration, prosthetic design, hygiene accessibility, and radiographic bone levels.
Statistical analysis will evaluate associations between probing access and peri-implant bone loss at both patient and implant levels.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients attending participating clinics for the first time for maintenance, review, or treatment, with dental implants in function for at least three years
Key inclusion criteria (6 listed)
- Age ≥18 years
- Dental implants loaded for at least 3 years
- Implant-supported restorations (single, partial fixed, or full-arch)
- First visit to the clinic (maintenance, review, or treatment)
- Signed informed consent
Key exclusion criteria (4 listed)
- Exposure of the intraosseous portion of the implant
- Evident prosthetic misfit
- Inability to provide informed consent
- Lack of cooperation for clinical examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peri-implant probingThis is a non-interventional, observational cross-sectional multicenter study. No therapeutic, surgical, or pharmacological interventions are performed as part of the study. All procedures correspond to standard clinical practice and include: Peri-implant clinical examination, consisting of probing depth measurements at six sites per implant using a manual periodontal probe. When access is limited, a flexible plastic probe may be used. Assessment of probing accessibility, categorized according to the angulation and feasibility of probe insertion without prosthesis removal (possible, limited, or impossible). Recording of routine clinical parameters, including plaque presence, bleeding on probing, suppuration, and patient-reported hygiene practices. Radiographic assessment, consisting of standardized periapical radiographs obtained using a parallel technique for the evaluation of marginal bone levels. No modifications to the patients' treatment, prosthetic design, or maintenance protocol | Diagnostic test | – |
Primary outcome
Association between probing access and peri-implant radiographic bone loss
Time frame: Baseline (cross-sectional assessment)
Evaluation of whether limited or impossible probing access is associated with increased radiographic bone loss (measured in mm from implant platform to bone level).
5 secondary outcomes
Prevalence of implants with limited or no probing accessibility
Time frame: Assessed at the baseline visit (single cross-sectional evaluation)
Prevalence of non-hygienizable implant-supported prostheses
Time frame: Assessed at the baseline visit (single cross-sectional evaluation)
Association between hygiene accessibility and peri-implant bone loss
Time frame: Assessed at the baseline visit (single cross-sectional evaluation)
Clinical peri-implant parameters
Time frame: Assessed at the baseline visit (single cross-sectional evaluation)
Patient-related and implant-related factors associated with probing accessibility
Time frame: Assessed at the baseline visit (single cross-sectional evaluation)
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 13 Oct 2026.
- 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.
9 sites 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 and Peri-implant Bone Loss, run by Arrow Development at 9 sites 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 Maite Trobo (+34747426390, arrow@archealth.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between probing access and peri-implant radiographic bone loss (time frame: Baseline (cross-sectional assessment)). 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 13 Oct 2026.