Peri-implant MucositisNCT06364982
Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease.
An observational study of Peri-implant Mucositis and Peri-Implantitis, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The aim of this study is to analyse contiguous dental implants and its peri-implant status depending on different inter-implant distances. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis, Peri-Implantitis
- What is being tested?
- Two contiguous dental implants placed with less ≤ 3mm from each other. and Two contiguous dental implants placed with > 3mm from each other.
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 5 Apr 2024to 31 Dec 2024
- 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: 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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clínica Universitaria de Odontologia
Sant Cugat del Vallès, Barcelona, 08195
Enrique Roldan, Dentist, 935042030 ext. +34, clinica@uic.es
About this study
Official title: Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease. A Multi-center Cross-sectional Study
The aim of this study is to analyse contiguous dental implants and its peri-implant status depending on different inter-implant distances.
Read the 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.
- Conditions
- Peri-implant Mucositis, Peri-Implantitis
- Being tested
- Two contiguous dental implants placed with less ≤ 3mm from each other., Two contiguous dental implants placed with > 3mm from each other.
- Keywords
- Peri-implantitis, Peri-implant diseases, Peri-implant mucositis, Inter-implant distances
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two contiguous dental implants placed with less ≤ 3mm from each other.Diagnostic test
Implant Placement of 2 contiguous dental implants with less ≤ 3mm from each other.
Two contiguous dental implants placed with > 3mm from each other.Diagnostic test
Implant Placement of 2 contiguous dental implants with > 3mm from each other.
| Study group | Role | What they receive |
|---|---|---|
| Inter-implant distance ≤ 3mm | Presence of an inter-implant distance ≤ 3mm Receives: Diagnostic Test: Two contiguous dental implants placed with less ≤ 3mm from each other. | |
| Inter-implant distance ≥ 3mm | Presence of an inter-implant distance ≥ 3mm Receives: Diagnostic Test: Two contiguous dental implants placed with > 3mm from each other. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of peri-implant diseases.
Prevalence of peri-implant mucositis and peri-implantitis.
Measured: At least 36 months of function - at the moment of the evaluation
Secondary outcomes (21)
FMPI
Full Mouth Plaque Index
Measured: At least 36 months of function - at the moment of the evaluation
FMBI
Full Mouth Bleeding Index
Measured: At least 36 months of function - at the moment of the evaluation
mPI
modified Plaque Index
Measured: At least 36 months of function - at the moment of the evaluation
mBI
modified Bleeding Index
Measured: At least 36 months of function - at the moment of the evaluation
SoP
Suppuration on Probing
Measured: At least 36 months of function - at the moment of the evaluation
PPD
Probing Pocket Depth
Measured: At least 36 months of function - at the moment of the evaluation
MR
Mucosal Recession
Measured: At least 36 months of function - at the moment of the evaluation
KM
Keratinized Mucosa
Measured: At least 36 months of function - at the moment of the evaluation
Implant location
Implant location in the oral cavity
Measured: At least 36 months of function - at the moment of the evaluation
Implant position
Implant position in the oral cavity
Measured: At least 36 months of function - at the moment of the evaluation
Implant type
Implant type used
Measured: At least 36 months of function - at the moment of the evaluation
Implant brand
Brand of the implant used
Measured: At least 36 months of function - at the moment of the evaluation
Implant roughness
Type of implant roughness
Measured: At least 36 months of function - at the moment of the evaluation
Implant diameter
Type of implant diameter
Measured: At least 36 months of function - at the moment of the evaluation
Implant length
Length of the implant
Measured: At least 36 months of function - at the moment of the evaluation
Apico-coronal position of the implant
Apico-coroal position
Measured: At least 36 months of function - at the moment of the evaluation
Inter-implant distances (IID)
Inter-implant distance
Measured: At least 36 months of function - at the moment of the evaluation
Implant placement protocol
Moment of the implant placement
Measured: At least 36 months of function - at the moment of the evaluation
Bone grafting procedures (BGP) at implant placement
Bone grafting associated with the implant placement
Measured: At least 36 months of function - at the moment of the evaluation
Implant-supported restorations
Screwed or Cemented
Measured: At least 36 months of function - at the moment of the evaluation
Cleansability of the prosthesis
Cleansable, difficult or impossible to clean
Measured: At least 36 months of function - at the moment of the evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start5 Apr 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant MucositisStudies 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
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiago Ribeiro Amaral, Universitat Internacional de Catalunya
- Investigators
- Cristina V Vallès, PhD, Study director, Department of Periodontology, University Internacional de Cataluña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364982
- Sponsor's protocol ID
- PER-ECL-2023-05
- Status last verified
- Jul 2024
- First submitted
- 31 Jan 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease. A Multi-center Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06364982
- Acronym / sponsor ID
- PER-ECL-2023-05
- Conditions
- Peri-implant Mucositis, Peri-Implantitis
- Keywords
- Peri-implantitis, Peri-implant diseases, Peri-implant mucositis, Inter-implant distances
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Apr 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inter-implant distance ≤ 3mm | – | Diagnostic Test: Two contiguous dental implants placed with less ≤ 3mm from each other.Presence of an inter-implant distance ≤ 3mm |
| Inter-implant distance ≥ 3mm | – | Diagnostic Test: Two contiguous dental implants placed with > 3mm from each other.Presence of an inter-implant distance ≥ 3mm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two contiguous dental implants placed with less ≤ 3mm from each other.Implant Placement of 2 contiguous dental implants with less ≤ 3mm from each other. | Diagnostic test | Inter-implant distance ≤ 3mm |
| Two contiguous dental implants placed with > 3mm from each other.Implant Placement of 2 contiguous dental implants with > 3mm from each other. | Diagnostic test | Inter-implant distance ≥ 3mm |
Primary outcome
Prevalence of peri-implant diseases.
Time frame: At least 36 months of function - at the moment of the evaluation
Prevalence of peri-implant mucositis and peri-implantitis.
21 secondary outcomes
FMPI
Time frame: At least 36 months of function - at the moment of the evaluation
FMBI
Time frame: At least 36 months of function - at the moment of the evaluation
mPI
Time frame: At least 36 months of function - at the moment of the evaluation
mBI
Time frame: At least 36 months of function - at the moment of the evaluation
SoP
Time frame: At least 36 months of function - at the moment of the evaluation
PPD
Time frame: At least 36 months of function - at the moment of the evaluation
MR
Time frame: At least 36 months of function - at the moment of the evaluation
KM
Time frame: At least 36 months of function - at the moment of the evaluation
Implant location
Time frame: At least 36 months of function - at the moment of the evaluation
Implant position
Time frame: At least 36 months of function - at the moment of the evaluation
Implant type
Time frame: At least 36 months of function - at the moment of the evaluation
Implant brand
Time frame: At least 36 months of function - at the moment of the evaluation
Implant roughness
Time frame: At least 36 months of function - at the moment of the evaluation
Implant diameter
Time frame: At least 36 months of function - at the moment of the evaluation
Implant length
Time frame: At least 36 months of function - at the moment of the evaluation
Apico-coronal position of the implant
Time frame: At least 36 months of function - at the moment of the evaluation
Inter-implant distances (IID)
Time frame: At least 36 months of function - at the moment of the evaluation
Implant placement protocol
Time frame: At least 36 months of function - at the moment of the evaluation
Bone grafting procedures (BGP) at implant placement
Time frame: At least 36 months of function - at the moment of the evaluation
Implant-supported restorations
Time frame: At least 36 months of function - at the moment of the evaluation
Cleansability of the prosthesis
Time frame: At least 36 months of function - at the moment of the evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
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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.
Cristina V Vallès, PhD study director
Department of Periodontology, University Internacional de Cataluña
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-implant Mucositis and Peri-Implantitis, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 5 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: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ioannis Terpou, MSc (+306978218177, ioannisterpou.95@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of peri-implant diseases. (time frame: At least 36 months of function - at the moment of the evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2024.