Dental ImplantsNCT07671456
Impact of Periodontitis Grading on Peri-Implant Clinical and Bone Health: A 60-Month Prospective Study
An observational study of Dental Implants and Aggressive Periodontitis, run by University of Campinas, Brazil.
Trial summary
This prospective cohort study evaluated the effect of periodontitis grading on peri-implant clinical and radiographic outcomes over a 60-month follow-up. Fifty-five partially edentulous patients were classified into three groups according to periodontal status: generalized aggressive periodontitis (Grade C)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Aggressive Periodontitis, Chronic Periodontitis
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jan 2019
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with or without a history of periodontitis were included in the study
Who may be able to join
- Age ≥ 18 years.
- Previous diagnosis of aggressive periodontitis, chronic periodontitis, or no history of periodontitis.
- Completion of periodontal treatment at least 1 year before study enrollment.
- Enrollment in supportive periodontal therapy.
- Plaque Index < 20% at study onset.
- Bleeding on Probing < 20% at study onset.
- Presence of at least one single edentulous space with adjacent teeth.
- Sufficient bone and soft tissue volume for implant placement without the need for reconstructive procedures.
Who cannot join
- Systemic conditions that contraindicate implant surgery.
- Use of systemic antimicrobial therapy within 6 months before implant placement.
- Untreated or uncontrolled aggressive periodontitis.
- Untreated or uncontrolled chronic periodontitis.
- Pregnancy or breastfeeding.
- Need for bone grafting or soft tissue grafting procedures.
- Current smokers or former smokers.
About this study
Official title: Impact of Periodontitis Grading on Clinical and Bone Peri-Implant Health: Longitudinal, Prospective, 60-Month Follow-Up Study
This prospective cohort study evaluated the effect of periodontitis grading on peri-implant clinical and radiographic outcomes over a 60-month follow-up. Fifty-five partially edentulous patients were classified into three groups according to periodontal status: generalized aggressive periodontitis (Grade C), generalized chronic periodontitis (Grade B), and no history of periodontitis. A total of 92 implants (tissue- or bone-level) were placed and restored with single crowns, followed by biannual supportive periodontal therapy.
Peri-implant clinical parameters (probing depth, clinical attachment level, plaque index, and bleeding on probing), marginal bone level changes, peri-implantitis incidence, and implant survival were assessed up to 60 months after prosthetic loading.
The objective was to determine whether periodontal history and grading influence long-term peri-implant outcomes under maintenance therapy.
Read the detailed description
This prospective cohort study was conducted to evaluate the long-term influence of a history of periodontitis on peri-implant clinical and radiographic outcomes in partially edentulous patients. Patients were classified according to their periodontal status into three groups: generalized aggressive periodontitis (currently classified as Grade C periodontitis), generalized chronic periodontitis (Grade B periodontitis), and individuals without a history of periodontitis.
A total of 55 patients received 92 dental implants, either tissue-level or bone-level, placed in healed sites and restored with single screw-retained crowns. All patients were enrolled in a structured supportive periodontal therapy program and were followed for 60 months after prosthetic loading.
Peri-implant and periodontal health were assessed longitudinally using clinical parameters (probing depth, clinical attachment levels, plaque accumulation, and bleeding on probing) as well as radiographic evaluation of marginal bone level changes. Assessments were performed at multiple time points throughout follow-up to monitor tissue stability and disease occurrence.
The primary aim of the study was to compare peri-implant outcomes among patients with different periodontal backgrounds and to determine whether a history and severity of periodontitis influence long-term implant success and disease incidence under strict maintenance conditions. Secondary outcomes included evaluation of marginal bone remodeling, incidence of peri-implantitis, and implant survival over time.
- Conditions
- Dental Implants, Aggressive Periodontitis, Chronic Periodontitis, Staging, Peri-implantitis
- Medical subject headings
- Aggressive Periodontitis, Chronic Periodontitis, Peri-Implantitis
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 |
|---|---|---|
| GAP Group | Patients with a history of generalized aggressive periodontitis, rehabilitated with dental implants. | |
| GCP Group | Patients with a history of generalized chronic periodontitis, rehabilitated with dental implants. | |
| PPH Group | Periodontally healthy patients or Patients with no history of periodontitis (no site with probing depth > 3mm and bleeding on probing < 20%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone level changes around dental implants evaluated radiographically.
Primary Outcome
Measured: Over a 60-month follow-up period.
Secondary outcomes (3)
Peri-implant probing depth (PPD) at follow-up visits
Secondary Outcome Measure
Measured: Over a 60-month follow-up period
Bleeding on probing (BoP) around implants
Measured: 60 months follow-up
Implant survival rate
Measured: 60 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startJan 2011
- Primary completionJun 2017
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies 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
- 70 participants (actual)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Casarin, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671456
- Sponsor's protocol ID
- 0015.0.167.0000-10
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pimentel SP, Shiota R, Cirano FR, Casarin RCV, Pecorari VGA, Casati MZ, Haas AN, Ribeiro FV. Occurrence of peri-implant diseases and risk indicators at the patient and implant levels: A multilevel cross-sectional study. J Periodontol. 2018 Sep;89(9):1091-1100. doi: 10.1002/JPER.17-0599. Epub 2018 Aug 8.
PubMed 29761866Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S313-S318. doi: 10.1002/JPER.17-0739.
PubMed 29926955Salvi GE, Stahli A, Imber JC, Sculean A, Roccuzzo A. Physiopathology of peri-implant diseases. Clin Implant Dent Relat Res. 2023 Aug;25(4):629-639. doi: 10.1111/cid.13167. Epub 2022 Dec 14.
PubMed 36515007Lang NP. Implant Dentistry: The Past, the Present, the Future. J Periodontal Res. 2025 Feb;60(2):97-100. doi: 10.1111/jre.13388. Epub 2025 Feb 21. No abstract available.
PubMed 39980414Karoussis IK, Salvi GE, Heitz-Mayfield LJ, Bragger U, Hammerle CH, Lang NP. Long-term implant prognosis in patients with and without a history of chronic periodontitis: a 10-year prospective cohort study of the ITI Dental Implant System. Clin Oral Implants Res. 2003 Jun;14(3):329-39. doi: 10.1034/j.1600-0501.000.00934.x.
PubMed 12755783
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Periodontitis Grading on Clinical and Bone Peri-Implant Health: Longitudinal, Prospective, 60-Month Follow-Up Study
- ClinicalTrials.gov ID
- NCT07671456
- Acronym / sponsor ID
- 0015.0.167.0000-10
- Conditions
- Dental Implants, Aggressive Periodontitis, Chronic Periodontitis, Staging, Peri-implantitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 26 Jun 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 prospective cohort study evaluated the effect of periodontitis grading on peri-implant clinical and radiographic outcomes over a 60-month follow-up. Fifty-five partially edentulous patients were classified into three groups according to periodontal status: generalized aggressive periodontitis (Grade C), generalized chronic periodontitis (Grade B), and no history of periodontitis. A total of 92 implants (tissue- or bone-level) were placed and restored with single crowns, followed by biannual supportive periodontal therapy.
Peri-implant clinical parameters (probing depth, clinical attachment level, plaque index, and bleeding on probing), marginal bone level changes, peri-implantitis incidence, and implant survival were assessed up to 60 months after prosthetic loading.
The objective was to determine whether periodontal history and grading influence long-term peri-implant outcomes under maintenance therapy.
Detailed description
This prospective cohort study was conducted to evaluate the long-term influence of a history of periodontitis on peri-implant clinical and radiographic outcomes in partially edentulous patients. Patients were classified according to their periodontal status into three groups: generalized aggressive periodontitis (currently classified as Grade C periodontitis), generalized chronic periodontitis (Grade B periodontitis), and individuals without a history of periodontitis.
A total of 55 patients received 92 dental implants, either tissue-level or bone-level, placed in healed sites and restored with single screw-retained crowns. All patients were enrolled in a structured supportive periodontal therapy program and were followed for 60 months after prosthetic loading.
Peri-implant and periodontal health were assessed longitudinally using clinical parameters (probing depth, clinical attachment levels, plaque accumulation, and bleeding on probing) as well as radiographic evaluation of marginal bone level changes. Assessments were performed at multiple time points throughout follow-up to monitor tissue stability and disease occurrence.
The primary aim of the study was to compare peri-implant outcomes among patients with different periodontal backgrounds and to determine whether a history and severity of periodontitis influence long-term implant success and disease incidence under strict maintenance conditions. Secondary outcomes included evaluation of marginal bone remodeling, incidence of peri-implantitis, and implant survival over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GAP Group | – | –Patients with a history of generalized aggressive periodontitis, rehabilitated with dental implants. |
| GCP Group | – | –Patients with a history of generalized chronic periodontitis, rehabilitated with dental implants. |
| PPH Group | – | –Periodontally healthy patients or Patients with no history of periodontitis (no site with probing depth > 3mm and bleeding on probing < 20%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with or without a history of periodontitis were included in the study
Key inclusion criteria (8 listed)
- Age ≥ 18 years.
- Previous diagnosis of aggressive periodontitis, chronic periodontitis, or no history of periodontitis.
- Completion of periodontal treatment at least 1 year before study enrollment.
- Enrollment in supportive periodontal therapy.
- Plaque Index < 20% at study onset.
Key exclusion criteria (7 listed)
- Systemic conditions that contraindicate implant surgery.
- Use of systemic antimicrobial therapy within 6 months before implant placement.
- Untreated or uncontrolled aggressive periodontitis.
- Untreated or uncontrolled chronic periodontitis.
- Pregnancy or breastfeeding.
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
Marginal bone level changes around dental implants evaluated radiographically.
Time frame: Over a 60-month follow-up period.
Primary Outcome
3 secondary outcomes
Peri-implant probing depth (PPD) at follow-up visits
Time frame: Over a 60-month follow-up period
Bleeding on probing (BoP) around implants
Time frame: 60 months follow-up
Implant survival rate
Time frame: 60 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 29761866Pimentel SP, Shiota R, Cirano FR, Casarin RCV, Pecorari VGA, Casati MZ, Haas AN, Ribeiro FV. Occurrence of peri-implant diseases and risk indicators at the patient and implant levels: A multilevel cross-sectional study. J Periodontol. 2018 Sep;89(9):1091-1100. doi: 10.1002/JPER.17-0599. Epub 2018 Aug 8.
- Background: PubMed 29926955Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S313-S318. doi: 10.1002/JPER.17-0739.
- Background: PubMed 36515007Salvi GE, Stahli A, Imber JC, Sculean A, Roccuzzo A. Physiopathology of peri-implant diseases. Clin Implant Dent Relat Res. 2023 Aug;25(4):629-639. doi: 10.1111/cid.13167. Epub 2022 Dec 14.
- Background: PubMed 39980414Lang NP. Implant Dentistry: The Past, the Present, the Future. J Periodontal Res. 2025 Feb;60(2):97-100. doi: 10.1111/jre.13388. Epub 2025 Feb 21. No abstract available.
- Background: PubMed 12755783Karoussis IK, Salvi GE, Heitz-Mayfield LJ, Bragger U, Hammerle CH, Lang NP. Long-term implant prognosis in patients with and without a history of chronic periodontitis: a 10-year prospective cohort study of the ITI Dental Implant System. Clin Oral Implants Res. 2003 Jun;14(3):329-39. doi: 10.1034/j.1600-0501.000.00934.x.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants and Aggressive Periodontitis, run by University of Campinas, Brazil.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal bone level changes around dental implants evaluated radiographically. (time frame: Over a 60-month follow-up period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07671456, which also lists 5 linked publications.
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 26 Jun 2026.