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Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease.

Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease. A Multi-center Cross-sectional Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06364982
Enrollment
180
Registered
2024-04-15
Start date
2024-04-05
Completion date
2024-12-31
Last updated
2024-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-Implantitis, Peri-implant Mucositis

Keywords

Peri-implantitis, Peri-implant diseases, Peri-implant mucositis, Inter-implant distances

Brief summary

The aim of this study is to analyse contiguous dental implants and its peri-implant status depending on different inter-implant distances.

Detailed description

The present research project has been designed as a multicentric cross-sectional study. The STROBE guidelines have been followed in the design of this observational study. Ethical issues The study will be performed after the approval of the Ethics Committee of the Universitat Internacional de Catalunya (UIC) and Faculdade de Medicina Dentária da Universidade de Lisboa (FMDUL) and will be intended to be registered in clinicaltrials.gov. Also, this research will be conducted according to the principles outlined in the Declaration of Helsinki (revised, amended, and clarified in 2013). In addition, all study participants will provide written informed consent before participating in the study. Study population Subjects will be selected from an electronic database collected at the CUO (UIC) / CU (FMDUL) and composed of patients treated with at least two contiguous dental implants before 2021. This investigation will use a stratified random sampling based on year of implant placement to select a representative sample of subjects with implant-supported restorations conducted during the period 2001-2020 at the CUO and CU. Then, two examiners (I.T. / F.F.) will contact patients by telephone once every 2 days (with a maximum of 3 attempts) for an evaluation by the same investigators (I.T / F.F). Criteria for subject selection will be as follows: * The patient must be ≥18 years of age and systemically healthy; * Partially edentulous patients, rehabilitated until 2020 (i.e., a minimum of 3 years of function time) with at least two contiguous implant-supported restorations in the maxilla or mandible; * Screw or cemented-retained prosthesis; * Fixed dental prosthesis (i.e., single crowns and partial prosthesis); * No implant mobility. Moreover, the exclusion criteria will be the following: * Pregnant and lactating women; * Patients who have taken systemic antibiotics during the 3 months prior to the examination; * Patients being treated with drugs that may induce a gingival overgrowth; * Patients undergoing orthodontic treatment (since it can influence periodontal diagnosis); * Patients who have received mechanical debridement during the 3 months prior to the exam; * Patients who have received surgical treatment for peri-implantitis; * Psychophysical inability to carry out study procedures.

Interventions

DIAGNOSTIC_TESTTwo contiguous dental implants placed with less ≤ 3mm from each other.

Implant Placement of 2 contiguous dental implants with less ≤ 3mm from each other.

DIAGNOSTIC_TESTTwo contiguous dental implants placed with > 3mm from each other.

Implant Placement of 2 contiguous dental implants with \> 3mm from each other.

Sponsors

Universitat Internacional de Catalunya
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* The patient must be ≥18 years of age and systemically healthy; * Partially edentulous patients, rehabilitated until 2020 (i.e., a minimum of 3 years of function time) with at least two contiguous implant-supported restorations in the maxilla or mandible; * Screw or cemented-retained prosthesis; * Fixed dental prosthesis (i.e., single crowns and partial prosthesis); * No implant mobility.

Exclusion criteria

* Pregnant and lactating women; * Patients who have taken systemic antibiotics during the 3 months prior to the examination; * Patients being treated with drugs that may induce a gingival overgrowth; * Patients undergoing orthodontic treatment (since it can influence periodontal diagnosis); * Patients who have received mechanical debridement during the 3 months prior to the exam; * Patients who have received surgical treatment for peri-implantitis; * Psychophysical inability to carry out study procedures.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of peri-implant diseases.At least 36 months of function - at the moment of the evaluationPrevalence of peri-implant mucositis and peri-implantitis.

Secondary

MeasureTime frameDescription
Implant-supported restorationsAt least 36 months of function - at the moment of the evaluationScrewed or Cemented
FMPIAt least 36 months of function - at the moment of the evaluationFull Mouth Plaque Index
FMBIAt least 36 months of function - at the moment of the evaluationFull Mouth Bleeding Index
mPIAt least 36 months of function - at the moment of the evaluationmodified Plaque Index
mBIAt least 36 months of function - at the moment of the evaluationmodified Bleeding Index
SoPAt least 36 months of function - at the moment of the evaluationSuppuration on Probing
PPDAt least 36 months of function - at the moment of the evaluationProbing Pocket Depth
MRAt least 36 months of function - at the moment of the evaluationMucosal Recession
KMAt least 36 months of function - at the moment of the evaluationKeratinized Mucosa
Implant locationAt least 36 months of function - at the moment of the evaluationImplant location in the oral cavity
Bone grafting procedures (BGP) at implant placementAt least 36 months of function - at the moment of the evaluationBone grafting associated with the implant placement
Implant typeAt least 36 months of function - at the moment of the evaluationImplant type used
Implant brandAt least 36 months of function - at the moment of the evaluationBrand of the implant used
Implant roughnessAt least 36 months of function - at the moment of the evaluationType of implant roughness
Implant diameterAt least 36 months of function - at the moment of the evaluationType of implant diameter
Implant lengthAt least 36 months of function - at the moment of the evaluationLength of the implant
Apico-coronal position of the implantAt least 36 months of function - at the moment of the evaluationApico-coroal position
Inter-implant distances (IID)At least 36 months of function - at the moment of the evaluationInter-implant distance
Implant placement protocolAt least 36 months of function - at the moment of the evaluationMoment of the implant placement
Cleansability of the prosthesisAt least 36 months of function - at the moment of the evaluationCleansable, difficult or impossible to clean
Implant positionAt least 36 months of function - at the moment of the evaluationImplant position in the oral cavity

Countries

Spain

Contacts

Primary ContactIoannis Terpou, MSc
ioannisterpou.95@uic.es+306978218177
Backup ContactTiago R Amaral, MSc
tiagoamaral@edu.ulisboa.pt+351916067069

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026