Peri-implantitisNCT07844642
Timing of Success Evaluation After Flapless Treatment of Peri-Implantitis
An observational study of Peri-implantitis, run by University of Barcelona at 1 site in Spain.
Trial summary
Peri-implantitis is an inflammatory disease around dental implants that causes progressive loss of the bone supporting the implant. Current clinical guidelines recommend treating it first with a non-surgical approach and then checking treatment success, usually between 6 and 12 weeks later. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- Flapless non-surgical treatment of peri-implantitis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2026to Sep 2028
- 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: Adult patients with at least one dental implant in function for at least 12 months, diagnosed with peri-implantitis according to the 2017 World Workshop criteria, treated at the Hospital Odontològic Universitat de Barcelona.
Who may be able to join
- Patients aged 18 years or older.
- General health status compatible with dental treatment (ASA I-II).
- Ability to understand the study, sign the informed consent form, and comply with the follow-up protocol.
- Presence of one or more dental implants in function for at least 12 months, placed at any center, regardless of connection type or the presence of platform switching.
- Screw-retained implant-supported prostheses (single-unit, partial, or complete).
- Presence of at least one implant diagnosed with peri-implantitis, according to the criteria of the 2017 Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
Who cannot join
- Refusal to participate in the study or inability to provide informed consent.
- Non-acceptance of the proposed treatment.
- Pregnancy or breastfeeding.
- Treatment with drugs or presence of diseases that may alter the healing of peri-implant tissues or interfere with the response to treatment (e.g., immunosuppressants, systemic corticosteroids at immunosuppressive doses, or treatment with antiresorptive or antiangiogenic agents).
- Implants restored with cemented prostheses.
- Implants with mobility or with radiographic bone loss exceeding 50%.
- Surgical or non-surgical peri-implant treatment of the affected implant within the previous 12 months.
- Systemic antibiotic treatment within the previous 3 months.
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
Hospital Odontològic Universitat de Barcelona
L'Hospitalet de Llobregat, Barcelona
Camps Font, +34 620 189 707, phernade30@alumnes.ub.edu
About this study
Official title: Timing of Success Evaluation Following Flapless Treatment of Peri-Implantitis: A Prospective Case Series
Peri-implantitis is an inflammatory disease around dental implants that causes progressive loss of the bone supporting the implant. Current clinical guidelines recommend treating it first with a non-surgical approach and then checking treatment success, usually between 6 and 12 weeks later. However, it is not known whether this is the best time to check the results, since no previous studies have compared different follow-up time points.
This study will follow patients with peri-implantitis who receive the same non-surgical, flapless treatment. Their implants will be checked at five different times after treatment (6 and 12 weeks, and 6, 9, and 12 months) to see how the clinical outcome changes over time. The main goal is to find out how treatment success evolves at these different time points, and whether the results seen early (at 6 weeks) match the final results seen at 12 months
- Conditions
- Peri-implantitis
- Being tested
- Flapless non-surgical treatment of peri-implantitis
- Keywords
- Non-surgical treatment, Flapless treatment, Treatment success, Re-evaluation timing
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flapless non-surgical treatment of peri-implantitisProcedure or surgery
Non-surgical flapless treatment consisting of oral hygiene motivation and instructions, removal of the implant-supported prosthesis when possible, modification of the emergence profile when indicated, supra- and submucosal mechanical debridement using ultrasonic devices with periodontal tips and steel curettes, removal of granulation tissue, and curettage of the peri-implant mucosa. Followed by chlorhexidine gel twice daily for 15 days and systemic antibiotic therapy (metronidazole 500 mg three times daily for 7 days, or azithromycin 500 mg once daily for 3 days in case of allergy/contraindication)
| Study group | Role | What they receive |
|---|---|---|
| Flapless treatment | Not described Receives: Procedure: Flapless non-surgical treatment of peri-implantitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success Following Flapless Treatment of Peri-Implantitis
Clinical success, recorded dichotomously (success/no success), assessed at six sites per implant. An implant is classified as a clinical success when probing depth (PD) is ≤5 mm at all six sites, bleeding on probing is present at, at most, one site and presents as an isolated spot rather than a line or profuse bleeding, and suppuration is absent at all sites.
Measured: 6 weeks, 12 weeks, 6 months, 9 months, and 12 months after treatment
Secondary outcomes (29)
Age (Years)
Age at inclusion, recorded in completed years.
Measured: Baseline (T0)
Sex (Male/Female)
Sex of participants.
Measured: Baseline (T0)
Smoking Status (Never Smoker/Former Smoker/Current Smoker)
Smoking status classified as never smoker, former smoker, or current smoker. In current and former smokers, cumulative smoking exposure will be recorded in pack-years; in current smokers, daily cigarette consumption will also be recorded.
Measured: Baseline (T0)
Periodontal Diagnosis (Stage I-IV; Grade A-C)
Periodontal diagnosis according to the classification of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
Measured: Baseline (T0)
Arch (Maxilla/Mandible)
Location of the implant by dental arch.
Measured: Baseline (T0)
Location (Anterior/Premolar/Molar)
Implant location within the arch.
Measured: Baseline (T0)
Implant Type (Bone Level/Tissue Level)
Type of implant according to its design.
Measured: Baseline (T0)
Implant Length and Diameter (mm)
Implant length and diameter, recorded in millimeters.
Measured: Baseline (T0)
Surface Type (Machined/Rough)
Implant surface type.
Measured: Baseline (T0)
Implant-Abutment Connection Type (Internal/External)
Type of connection between implant and abutment.
Measured: Baseline (T0)
Time in Function (Years)
Time elapsed since implant placement, recorded in years.
Measured: Baseline (T0)
Prosthesis Type (Single-Unit/Partial/Multiple)
Type of implant-supported prosthesis.
Measured: Baseline (T0)
Intermediate Abutment (Yes/No)
Presence of an intermediate abutment.
Measured: Baseline (T0)
Prosthetic Modification During Treatment (Yes/No)
Whether a prosthetic modification was performed during the flapless treatment visit.
Measured: Flapless treatment visit (T-treatment)
Modified Plaque Index (0-3)
Presence of plaque, recorded at six sites per implant using the modified plaque index (Mombelli et al., 1987).
Measured: Baseline (T0), and at 6 and 12 weeks, and 6, 9, and 12 months (T1-T5)
Probing Depth (mm)
Distance, in millimeters, from the mucosal margin to the base of the peri-implant pocket, measured without the prosthesis in place, recorded at six sites per implant using a PCP-UNC 15 periodontal probe.
Measured: Baseline (T0), and at 6 and 12 weeks, and 6, 9, and 12 months (T1-T5)
Bleeding on Probing (Present/Absent)
Presence or absence of bleeding on probing, recorded at six sites per implant.
Measured: Baseline (T0), and at 6 and 12 weeks, and 6, 9, and 12 months (T1-T5)
Suppuration on Probing (Present/Absent)
Presence or absence of suppuration on probing, recorded at six sites per implant.
Measured: Baseline (T0), and at 6 and 12 weeks, and 6, 9, and 12 months (T1-T5)
Implant-Mucosa Distance (mm)
Distance between the mucosal margin and the implant shoulder, measured after prosthesis removal at six sites per implant. Recorded as positive when the mucosal margin is apical to the implant shoulder, and negative when coronal to it.
Measured: Flapless treatment visit (T-treatment)
Keratinized Mucosa (mm)
Distance between the mucosal margin and the mucogingival junction, measured at six sites per implant.
Measured: Flapless treatment visit (T-treatment)
Retreatment Performed (Yes/No)
Whether retreatment (re-instrumentation without adjunctive systemic antibiotics) was performed, and timing.
Measured: 12 weeks, and 6, 9, and 12 months (T2-T5)
Need for Surgical Peri-Implant Treatment (Yes/No)
Whether additional surgical peri-implant treatment was required, and timing.
Measured: 12 weeks, and 6, 9, and 12 months (T2-T5)
Implant Loss (Yes/No)
Whether the implant was lost/extracted, and timing.
Measured: 12 weeks, and 6, 9, and 12 months (T2-T5)
Radiographic Defect Morphology (Supracrestal/Intrabony/Combined)
Morphology of the radiographic bone defect, classified as supracrestal, intrabony, or combined, assessed on periapical radiographs obtained using the long-cone paralleling technique and analyzed with ImageJ® software after calibration using the known implant length.
Measured: Baseline (T0)
Radiographic Bone Level (mm)
Distance, in millimeters, between the implant shoulder and the base of the bone defect, assessed on periapical radiographs obtained using the long-cone paralleling technique and analyzed with ImageJ® software after calibration using the known implant length.
Measured: Baseline (T0), and at 6 and 12 months (T3, T5), or at any other visit if clinically necessary
Intrabony Defect Depth (mm)
Depth of the intrabony component of the radiographic defect, assessed on periapical radiographs.
Measured: Baseline (T0)
Intrabony Defect Width (mm)
Width of the intrabony component of the radiographic defect, assessed on periapical radiographs.
Measured: Baseline (T0)
Intrabony Defect Angle (º)
Angle of the intrabony component of the radiographic defect, assessed on periapical radiographs.
Measured: Baseline (T0)
Treatment Trajectory (Success Without Retreatment/Success After Retreatment/Persistent Failure at 12 Months/Surgical Treatment or Implant Loss)
Implant status at the 12-month outcome, classified as: success without retreatment; success after retreatment; persistent failure at 12 months; or surgical treatment/implant loss. An implant is considered a treatment failure if classified as either persistent failure at 12 months or surgical treatment/implant loss.
Measured: 12 months (T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Octavi Camps-Font, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844642
- Sponsor's protocol ID
- 39/2026
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Success Evaluation Following Flapless Treatment of Peri-Implantitis: A Prospective Case Series
- ClinicalTrials.gov ID
- NCT07844642
- Acronym / sponsor ID
- 39/2026
- Conditions
- Peri-implantitis
- Keywords
- Non-surgical treatment, Flapless treatment, Treatment success, Re-evaluation timing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 28 Sep 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.
Peri-implantitis is an inflammatory disease around dental implants that causes progressive loss of the bone supporting the implant. Current clinical guidelines recommend treating it first with a non-surgical approach and then checking treatment success, usually between 6 and 12 weeks later. However, it is not known whether this is the best time to check the results, since no previous studies have compared different follow-up time points.
This study will follow patients with peri-implantitis who receive the same non-surgical, flapless treatment. Their implants will be checked at five different times after treatment (6 and 12 weeks, and 6, 9, and 12 months) to see how the clinical outcome changes over time. The main goal is to find out how treatment success evolves at these different time points, and whether the results seen early (at 6 weeks) match the final results seen at 12 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flapless treatment | – | Procedure: Flapless non-surgical treatment of peri-implantitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with at least one dental implant in function for at least 12 months, diagnosed with peri-implantitis according to the 2017 World Workshop criteria, treated at the Hospital Odontològic Universitat de Barcelona.
Key inclusion criteria (6 listed)
- Patients aged 18 years or older.
- General health status compatible with dental treatment (ASA I-II).
- Ability to understand the study, sign the informed consent form, and comply with the follow-up protocol.
- Presence of one or more dental implants in function for at least 12 months, placed at any center, regardless of connection type or the presence of platform switching.
- Screw-retained implant-supported prostheses (single-unit, partial, or complete).
Key exclusion criteria (8 listed)
- Refusal to participate in the study or inability to provide informed consent.
- Non-acceptance of the proposed treatment.
- Pregnancy or breastfeeding.
- Treatment with drugs or presence of diseases that may alter the healing of peri-implant tissues or interfere with the response to treatment (e.g., immunosuppressants, systemic corticosteroids at immunosuppressive doses, or treatment with antiresorptive or antiangiogenic agents).
- Implants restored with cemented prostheses.
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 |
|---|---|---|
| Flapless non-surgical treatment of peri-implantitisNon-surgical flapless treatment consisting of oral hygiene motivation and instructions, removal of the implant-supported prosthesis when possible, modification of the emergence profile when indicated, supra- and submucosal mechanical debridement using ultrasonic devices with periodontal tips and steel curettes, removal of granulation tissue, and curettage of the peri-implant mucosa. Followed by chlorhexidine gel twice daily for 15 days and systemic antibiotic therapy (metronidazole 500 mg three times daily for 7 days, or azithromycin 500 mg once daily for 3 days in case of allergy/contraindication) | Procedure or surgery | Flapless treatment |
Primary outcome
Clinical Success Following Flapless Treatment of Peri-Implantitis
Time frame: 6 weeks, 12 weeks, 6 months, 9 months, and 12 months after treatment
Clinical success, recorded dichotomously (success/no success), assessed at six sites per implant. An implant is classified as a clinical success when probing depth (PD) is ≤5 mm at all six sites, bleeding on probing is present at, at most, one site and presents as an isolated spot rather than a line or profuse bleeding, and suppuration is absent at all sites.
29 secondary outcomes
Age (Years)
Time frame: Baseline (T0)
Sex (Male/Female)
Time frame: Baseline (T0)
Smoking Status (Never Smoker/Former Smoker/Current Smoker)
Time frame: Baseline (T0)
Periodontal Diagnosis (Stage I-IV; Grade A-C)
Time frame: Baseline (T0)
Arch (Maxilla/Mandible)
Time frame: Baseline (T0)
Location (Anterior/Premolar/Molar)
Time frame: Baseline (T0)
Implant Type (Bone Level/Tissue Level)
Time frame: Baseline (T0)
Implant Length and Diameter (mm)
Time frame: Baseline (T0)
Surface Type (Machined/Rough)
Time frame: Baseline (T0)
Implant-Abutment Connection Type (Internal/External)
Time frame: Baseline (T0)
Time in Function (Years)
Time frame: Baseline (T0)
Prosthesis Type (Single-Unit/Partial/Multiple)
Time frame: Baseline (T0)
Intermediate Abutment (Yes/No)
Time frame: Baseline (T0)
Prosthetic Modification During Treatment (Yes/No)
Time frame: Flapless treatment visit (T-treatment)
Modified Plaque Index (0-3)
Time frame: Baseline (T0), and at 6 and 12 weeks, and 6, 9, and 12 months (T1-T5)
Probing Depth (mm)
Time frame: Baseline (T0), and at 6 and 12 weeks, and 6, 9, and 12 months (T1-T5)
Bleeding on Probing (Present/Absent)
Time frame: Baseline (T0), and at 6 and 12 weeks, and 6, 9, and 12 months (T1-T5)
Suppuration on Probing (Present/Absent)
Time frame: Baseline (T0), and at 6 and 12 weeks, and 6, 9, and 12 months (T1-T5)
Implant-Mucosa Distance (mm)
Time frame: Flapless treatment visit (T-treatment)
Keratinized Mucosa (mm)
Time frame: Flapless treatment visit (T-treatment)
Retreatment Performed (Yes/No)
Time frame: 12 weeks, and 6, 9, and 12 months (T2-T5)
Need for Surgical Peri-Implant Treatment (Yes/No)
Time frame: 12 weeks, and 6, 9, and 12 months (T2-T5)
Implant Loss (Yes/No)
Time frame: 12 weeks, and 6, 9, and 12 months (T2-T5)
Radiographic Defect Morphology (Supracrestal/Intrabony/Combined)
Time frame: Baseline (T0)
Radiographic Bone Level (mm)
Time frame: Baseline (T0), and at 6 and 12 months (T3, T5), or at any other visit if clinically necessary
Intrabony Defect Depth (mm)
Time frame: Baseline (T0)
Intrabony Defect Width (mm)
Time frame: Baseline (T0)
Intrabony Defect Angle (º)
Time frame: Baseline (T0)
Treatment Trajectory (Success Without Retreatment/Success After Retreatment/Persistent Failure at 12 Months/Surgical Treatment or Implant Loss)
Time frame: 12 months (T5)
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 28 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Hospital Odontològic Universitat de Barcelona
L'Hospitalet de Llobregat, Spain
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 6 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 28 Sep 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success Following Flapless Treatment of Peri-Implantitis (time frame: 6 weeks, 12 weeks, 6 months, 9 months, and 12 months after 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 28 Sep 2026.