- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07633912
Local Factors in the Onset/Progression of Peri-implantitis: A Retrospective Study
With the increasing burden of peri-implantitis worldwide, interest in the management of this pathology has flourished. However, there is a lack of consensus in the search for a predictable therapy. Different therapeutic modalities have been advocated. Non-surgical therapy as a sole modality is often insufficient to resolve inflammation. Surgical interventions have demonstrated more favorable results. Among these, evidence supported the application of resective, reconstructive or combined approaches to limit progressive bone loss and achieve soft tissue health. However, to date, the most appropriate modality is unknown and the decision-making process derives from the understanding gained in the management of periodontitis.
A very relevant aspect of peri-implantitis is that the prevalence tends to be higher at the patient level than at the implant level. This indicates that it is a pathology in which there are localized factors that may contribute to the onset and/or perpetuation of the pathology. Some of the factors that have been demonstrated in the literature point to the characteristics of the peri-implant soft tissues, as well as the position of the dental implants. However, the role of each local factor in the predisposition or protection of peri-implant disease or health is still largely unknown. The objective of this study is therefore to evaluate, in partially edentulous patients with multiple implants, the localized factors associated with peri-implantitis.
Study Overview
Detailed Description
Variables to explore:
Patient-related variables:
- Periodontal health (health, pathology)
- Periodontal status classification (stage, grade)
- Smoker (S, NS, FS)
- Compliance (NC, C, CE)
- Age (y)
- Time since implants (y)
- Pathology (DM, CVD, OP, other)
- Medication
- Anticoagulant (y/n)
- Plaque control (<20%, >20%, >50%)
Clinical variables:
- Keratinized mucosa (narrow, wide, lack)
- Vestibule (Deep ≥4mm, shallow <4mm, lack)
- Number of implants supporting the prosthesis (n)
- Implant location in the fixed prosthesis (mesial, distal, medial)
- Interproximal access with a 0.5mm brush between implants (IP-i)
- Interproximal access with a 0.5mm brush between implants implant-tooth (IP-t)
- Prosthesis type (SC, FPD)
- Cemented or screw-retained (C, S)
- Ceramic to connection (Y/N)
- Prosthesis material (Zr, Cr-Co)
- Implant (NB, ST, TC, DT, BTI, other)
- Implant diameter (mm)
- Implant length (mm)
- Position (M, PM, A, a, pm, m)
Radiographic variables:
- Distance between implants (m-d)
- Distance to adjacent tooth (m-d)
- Occlusal deviation towards buccal-lingual (b-l)
- Apico-coronal position with respect to adjacent tooth (a-c) with respect to LAC
- Apico-coronal position with respect to adjacent implant (a-c) with respect to coronal
- Inclination (implant deviation º) (m-d), (b-l) and º
- Defect configuration (Monje et al. 2019)
- Implant type (BL, TL)
- Transmucosal abutment (Y, N, short <2mm, long ≥2mm)
- Inadequate implant-prosthesis connection (Ill-fitting)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Badajoz, Spain, 06011
- Centro de Implantologia Cirugia Oral y Maxilofacial
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Partially edentulous patients
- Peri-implantitis and non-peri-implantitis implants
- Readable x-ray and clinical signs of inflammation/health
Exclusion Criteria:
- Complete edentulous patients
- Inconsistent definition of peri-implantitis
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peri-implantitis
Time Frame: >12 months
|
Bone loss (≥3mm) occurring with clinical signs of inflammation
|
>12 months
|
Collaborators and Investigators
Investigators
- Study Chair: Alberto Monje Correa, DDS, MS, PhD, CICOM MONJE
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
- 18002909(B)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Peri-Implantitis
-
University of ManitobaUnknownPeri ImplantitisCanada
-
Istanbul Medipol University HospitalAnkara University; Ankara Medipol University; Lokman Hekim UniversityCompletedPeri Implantitis | Peri-Implant Health | Peri Implant MucositisTurkey (Türkiye)
-
King Abdullah University HospitalJordan University of Science and TechnologyCompletedPeri-Implantitis and Peri-implant MucositisJordan
-
University of PittsburghRecruiting
-
Research Centre for Medical Genetics, Russian FederationCompleted
-
University of ValenciaCompletedEarly Apical Peri-implantitis
-
PolyPid Ltd.MIS Implant Technologies, LtdCompleted
-
Rambam Health Care CampusCompletedDental Implants,Peri-implantitis,SmokingIsrael
-
Recep Tayyip Erdogan UniversityNot yet recruitingPeri Implantitis | Peri Implant Mucositis
Clinical Trials on Dental implant
-
ZimVieCompletedPartial Edentulism | Tooth DiseaseUnited States
-
University of Alabama at BirminghamZimmer DentalCompleted
-
Cairo UniversityRecruitingHorizontal Atrophy of Edentulous Alveolar RidgeEgypt
-
Cairo UniversityUnknown
-
Aula Dental AvanzadaCompletedDental Implant Failed | Dental Prosthesis FailureSpain
-
Ankara UniversityCompleted
-
Universidad de GranadaCompletedJaw, Edentulous, PartiallySpain
-
The University of Hong KongRecruitingDental Implant Failed | Dental Implants | Single Tooth LostGermany, Hong Kong
-
Institut Straumann AGAvaniaCompletedDental Implants, Single-ToothGermany, Hong Kong, Portugal
-
Federal University of Rio Grande do SulRecruiting