Peri-ImplantitisNCT05804760
Predictive Value of Reduced Keratinized Mucosa on the Secondary Prevention of Peri-implant Mucositis and Periimplantitis in Patients Attending Regular Supportive Peri-implant Care. A Longitudinal Analysis
An observational study of Peri-Implantitis and Peri-implant Mucositis, run by Hannover Medical School at 1 site in Germany.
Trial summary
Capture of the potential risk factor "lack of band of keratinised mucosa" over a period of up to 5 years. Recording of peri-implant inflammatory processes in study participants that are not recorded during normal tooth cleaning Registration of the extent of radiographic bone loss. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Peri-implant Mucositis, Lack of Keratinized Gingiva
- What is being tested?
- Measurement of implant parameters
- How many people
- 104 participants
- Where
- 1 siteGermany
- Study dates
- 12 Feb 2020to 17 Dec 2020
- 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: 104 patients with at least one root-shaped dental implant who took part in one of the previous studies and who were attending supportive peri-implant care (SPIC) at the Department of Prosthetic Dentistry and Biomedical Materials Science of Hannover Medical School were asked to participate in the study.
Who may be able to join
- Patients aged at least 18 years who have at least one root-form dental implant in situ and were part of the first (DOI10.1111/clr.13432) and/or the second (DOI 10.1007/s00784-020-03422-1) observational study
Who cannot join
- Systemic antibiotic use up to 3 months before the examination
- pregnancy
- lactating mothers
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, 30625
About this study
- Capture of the potential risk factor "lack of band of keratinised mucosa" over a period of up to 5 years.
- Recording of peri-implant inflammatory processes in study participants that are not recorded during normal tooth cleaning
- Registration of the extent of radiographic bone loss. Bone resorption through analysis of existing X-ray images
- Individual therapy recommendation/individual supportive peri-implant care in case of peri-implant inflammation
- The present study was specifically designed to investigate the effect of reduced width of keratinized mucosa (KM) on the secondary prevention of peri-implant mucositis and peri-implantitis in patients attending a supportive peri-implant care program (SPIC) over an observation period of up to five years.
Read the detailed description
Patient information such as age, gender, history of periodontitis, edentulism, previous oral and maxillofacial tumor with a history of head and neck radiation, smoking habits, and metabolic diseases like diabetes mellitus were collected. Implant-specific information such as bone augmentation, year of implantation, implant position, implant level (bone level, tissue level), and number of implants were also documented. Prosthetic factors like the type of prosthesis (single crown, bridge construction, telescope prosthesis) and the type of attachment (cemented, screwed) were recorded. Clinical examination and measurement of clinical parameters were subsequently performed, including probing depth (PD) at six implant sites using a graduated periodontal probe, bleeding on probing or suppuration (BoP/Sup) occurring within 30 seconds after probing, and recessions measured in mm using a graduated periodontal probe between a defined clinical reference point and the implant mucosa.Participants were motivated to undergo regular SPIC, with frequency based on their individual risk factors. Patients without increased risk were encouraged to attend a 6-month recall. If bleeding or suppuration occurred, the frequency of SPIC was increased to monthly controls with oral hygiene instruction and plaque removal. Peri-implantitis therapy was initiated in patients with radiographically detectable bone loss, followed by lifelong SPIC. The modified plaque index (mPl) and full mouth plaque score API were used to assess local plaque accumulation and compliance. The modified gingival index (mGI) was used to assess the inflammatory state of the soft tissue. The mucositis severity score (MSS) was used to investigate the initiation and progression of peri-implant mucositis, with scores ≥18 indicating advanced inflammation. KM impact on MSS values <8 and ≥18 was investigated. Periodontal screening index (PSI) was used to classify the general periodontal condition of the patients by dividing the dentition into sextants. The width of the KM mucogingival junction was assessed using the "rolling technique." Radiographs were analyzed using byzznxt to diagnose possible radiological bone resorption. An individual diagnosis was made for each implant at the end of the examination, and data was collected following a standardized operating procedure and saved electronically.
- Being tested
- Measurement of implant parameters
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of implant parametersDiagnostic test
- Examination of the inclusion criteria
- Medical history/patient-specific data (smoking, tumour diseases, radiation, gender, number of implants, history of periodontitis).
- Recording of implant-specific parameters (measurement depth at six sites per implant(probing depth/PD), bleeding and or pus on probing (BOP) at six measurement sites per implant, condition of the peri-implant mucosa using the modified plaque index(mPI) and the modified ginigiva index (mGI), measurement of the width of the keratinised mucosa(KM), type of denture, approximal plaque index (API), radiographically detectable bone resorption.
| Study group | Role | What they receive |
|---|---|---|
| General population (i) | All participants of the study, including any periodontal condition. Receives: Diagnostic Test: Measurement of implant parameters | |
| Periodontally healthy patients with history of periodontitis (ii) | Patients whose current periodontal condition is healthy but who have developed periodontitis in the past. Receives: Diagnostic Test: Measurement of implant parameters | |
| Periodontally healthy patients without history of periodontitis (iii) | Patients whose current periodontal condition is healthy, who have also not had periodontitis in the past. Receives: Diagnostic Test: Measurement of implant parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protective value of keratinized mucosa around dental implants in periodontal healthy patients
Keratinized mucosa is a significant protective factor for the progression of peri-implant mucositis to severe peri-implant mucositis and to peri-implantitis in patients without history of periodontitis attending regular SPIC over a period of up to five years.
Measured: Up to five years
Secondary outcomes (1)
Mucositis severity score (MSS) related to the supported peri implant care (SPIC)
- The MSS ≤6 is a reasonable cut-off to define the endpoint of peri-implantitis treatment, define the entrance of the patient into SPIC and is an indicator for a successful SPIC program.
- MSS scores 7-17 indicate an elevated risk of disease progression and support the clinicians in decision making on reevaluating frequency and protocol of the patients individual SPIC.
- MSS scores ≥18 indicate that SPIC is not enough and (non-) surgical peri-implantitis treatment should be considered.
Measured: Up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start12 Feb 2020
- Primary completion23 Oct 2020
- Study completion17 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies 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
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804760
- Sponsor's protocol ID
- 9228_BO_S_2020
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Reduced Keratinized Mucosa on the Secondary Prevention of Peri-implant Mucositis and Periimplantitis in Patients Attending Regular Supportive Peri-implant Care. A Longitudinal Analysis
- ClinicalTrials.gov ID
- NCT05804760
- Acronym / sponsor ID
- 9228_BO_S_2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 7 Apr 2023 (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.
- Capture of the potential risk factor "lack of band of keratinised mucosa" over a period of up to 5 years.
- Recording of peri-implant inflammatory processes in study participants that are not recorded during normal tooth cleaning
- Registration of the extent of radiographic bone loss. Bone resorption through analysis of existing X-ray images
- Individual therapy recommendation/individual supportive peri-implant care in case of peri-implant inflammation
- The present study was specifically designed to investigate the effect of reduced width of keratinized mucosa (KM) on the secondary prevention of peri-implant mucositis and peri-implantitis in patients attending a supportive peri-implant care program (SPIC) over an observation period of up to five years.
Detailed description
Patient information such as age, gender, history of periodontitis, edentulism, previous oral and maxillofacial tumor with a history of head and neck radiation, smoking habits, and metabolic diseases like diabetes mellitus were collected. Implant-specific information such as bone augmentation, year of implantation, implant position, implant level (bone level, tissue level), and number of implants were also documented. Prosthetic factors like the type of prosthesis (single crown, bridge construction, telescope prosthesis) and the type of attachment (cemented, screwed) were recorded. Clinical examination and measurement of clinical parameters were subsequently performed, including probing depth (PD) at six implant sites using a graduated periodontal probe, bleeding on probing or suppuration (BoP/Sup) occurring within 30 seconds after probing, and recessions measured in mm using a graduated periodontal probe between a defined clinical reference point and the implant mucosa.Participants were motivated to undergo regular SPIC, with frequency based on their individual risk factors. Patients without increased risk were encouraged to attend a 6-month recall. If bleeding or suppuration occurred, the frequency of SPIC was increased to monthly controls with oral hygiene instruction and plaque removal. Peri-implantitis therapy was initiated in patients with radiographically detectable bone loss, followed by lifelong SPIC. The modified plaque index (mPl) and full mouth plaque score API were used to assess local plaque accumulation and compliance. The modified gingival index (mGI) was used to assess the inflammatory state of the soft tissue. The mucositis severity score (MSS) was used to investigate the initiation and progression of peri-implant mucositis, with scores ≥18 indicating advanced inflammation. KM impact on MSS values <8 and ≥18 was investigated. Periodontal screening index (PSI) was used to classify the general periodontal condition of the patients by dividing the dentition into sextants. The width of the KM mucogingival junction was assessed using the "rolling technique." Radiographs were analyzed using byzznxt to diagnose possible radiological bone resorption. An individual diagnosis was made for each implant at the end of the examination, and data was collected following a standardized operating procedure and saved electronically.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General population (i) | – | Diagnostic Test: Measurement of implant parametersAll participants of the study, including any periodontal condition. |
| Periodontally healthy patients with history of periodontitis (ii) | – | Diagnostic Test: Measurement of implant parametersPatients whose current periodontal condition is healthy but who have developed periodontitis in the past. |
| Periodontally healthy patients without history of periodontitis (iii) | – | Diagnostic Test: Measurement of implant parametersPatients whose current periodontal condition is healthy, who have also not had periodontitis in the past. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 104 patients with at least one root-shaped dental implant who took part in one of the previous studies and who were attending supportive peri-implant care (SPIC) at the Department of Prosthetic Dentistry and Biomedical Materials Science of Hannover Medical School were asked to participate in the study.
Key inclusion criteria (1 listed)
- Patients aged at least 18 years who have at least one root-form dental implant in situ and were part of the first (DOI10.1111/clr.13432) and/or the second (DOI 10.1007/s00784-020-03422-1) observational study
Key exclusion criteria (3 listed)
- Systemic antibiotic use up to 3 months before the examination
- pregnancy
- lactating mothers
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 |
|---|---|---|
| Measurement of implant parameters1. Examination of the inclusion criteria 2. Medical history/patient-specific data (smoking, tumour diseases, radiation, gender, number of implants, history of periodontitis). 3. Recording of implant-specific parameters (measurement depth at six sites per implant(probing depth/PD), bleeding and or pus on probing (BOP) at six measurement sites per implant, condition of the peri-implant mucosa using the modified plaque index(mPI) and the modified ginigiva index (mGI), measurement of the width of the keratinised mucosa(KM), type of denture, approximal plaque index (API), radiographically detectable bone resorption. | Diagnostic test | General population (i), Periodontally healthy patients with history of periodontitis (ii), Periodontally healthy patients without history of periodontitis (iii) |
Primary outcome
Protective value of keratinized mucosa around dental implants in periodontal healthy patients
Time frame: Up to five years
Keratinized mucosa is a significant protective factor for the progression of peri-implant mucositis to severe peri-implant mucositis and to peri-implantitis in patients without history of periodontitis attending regular SPIC over a period of up to five years.
1 secondary outcome
Mucositis severity score (MSS) related to the supported peri implant care (SPIC)
Time frame: Up to five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-Implantitis and Peri-implant Mucositis, run by Hannover Medical School at 1 site in Germany.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 7 Apr 2023. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protective value of keratinized mucosa around dental implants in periodontal healthy patients (time frame: Up to five years). 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 7 Apr 2023.