NCT07671456

Brief 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), 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

6.4 years

First QC Date

June 22, 2026

Last Update Submit

June 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Marginal bone level changes around dental implants evaluated radiographically.

    Primary Outcome

    Over a 60-month follow-up period.

Secondary Outcomes (3)

  • Peri-implant probing depth (PPD) at follow-up visits

    Over a 60-month follow-up period

  • Bleeding on probing (BoP) around implants

    60 months follow-up

  • Implant survival rate

    60 months follow-up

Study Arms (3)

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%)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with or without a history of periodontitis were included in the study

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 29761866BACKGROUND
  • 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.

    PMID: 29926955BACKGROUND
  • 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.

    PMID: 36515007BACKGROUND
  • 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.

    PMID: 39980414BACKGROUND
  • 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.

    PMID: 12755783BACKGROUND

MeSH Terms

Conditions

Aggressive PeriodontitisChronic PeriodontitisPeri-Implantitis

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Periodontology

Study Record Dates

First Submitted

June 22, 2026

First Posted

June 26, 2026

Study Start

January 1, 2011

Primary Completion

June 1, 2017

Study Completion

January 1, 2019

Last Updated

June 26, 2026

Record last verified: 2026-06