- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07671456
Impact of Periodontitis Grading on Peri-Implant Clinical and Bone Health: A 60-Month Prospective Study
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.
Study Overview
Status
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marginal bone level changes around dental implants evaluated radiographically.
Time Frame: Over a 60-month follow-up period.
|
Primary Outcome
|
Over a 60-month follow-up period.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peri-implant probing depth (PPD) at follow-up visits
Time Frame: Over a 60-month follow-up period
|
Secondary Outcome Measure
|
Over a 60-month follow-up period
|
|
Bleeding on probing (BoP) around implants
Time Frame: 60 months follow-up
|
60 months follow-up
|
|
|
Implant survival rate
Time Frame: 60 months follow-up
|
60 months follow-up
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Berglundh 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.
- Karoussis 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.
- 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.
- Salvi 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.
- Lang 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0015.0.167.0000-10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aggressive Periodontitis
-
Tokat Gaziosmanpasa UniversityCompletedChronic Periodontitis | Localized Aggressive PeriodontitisTurkey
-
Universidade Estadual Paulista Júlio de Mesquita...UnknownAggressive Periodontitis, Generalized
-
Istanbul UniversityCompletedPeriodontitis, AggressiveTurkey (Türkiye)
-
Asem Mohammed Kamel AliCompletedMolar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis) | Generalized Grade C Periodontitis (Generalized Aggressive Periodontitis)Egypt
-
Peking UniversityCompletedAggressive Periodontitis, GeneralizedChina
-
University of Campinas, BrazilCompletedGeneralized Aggressive Periodontitis
-
University of Campinas, BrazilCompletedGeneralized Aggressive Periodontitis
-
Universidade Estadual Paulista Júlio de Mesquita...CompletedAggressive Periodontitis, GeneralizedBrazil
-
Al-Azhar UniversityCompletedLocalized Aggressive Periodontitis
-
Kocaeli UniversityCompletedGeneralized Aggressive Periodontitis