Peri-implant MucositisNCT03497065
Dental Implant Care and Oral Hygiene Practices
An observational study of Peri-implant Mucositis and Peri-Implantitis, run by National University Health System, Singapore at 1 site in Singapore.
Trial summary
Objective: This study investigated how patients' knowledge, attitude, and perceptions influence their oral hygiene practices as well as peri-implant health. Materials and Methods: Participants with single implant crowns placed in 2007-2011 completed a questionnaire that examined their knowledge, attitude, and… Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis, Peri-Implantitis, Dental Plaque
- What is being tested?
- non-surgical periodontal treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 79 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Apr 2017to 30 Sep 2017
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population is made up 50.6% male and 49.4% female, mainly Chinese (87.3%), Indian (5%), Malay (3.8%), Caucasian (1.3%), Eurasian (1.3%), and Japanese (1.3%), with a mean age of 58.6 years old.
Who may be able to join
- English speaking patient
- Aged 21 years old or above
- Received at least 1 implant-supported single crown from NUH in the year 2007-2011 (in functional loading for at least 5 years)
Who cannot join
- Implant is used to restore overdentures or multi-unit restorations such as splinted crowns, fixed partial dentures, and cantilevers.
- Pregnant/lactating women
- Parkinson's disease or any other debilitating diseases
- Physical or mental disabilities that may impair oral hygiene practices
- Poorly controlled diabetes
- Heavy smoker (10 or more cigarettes per day)
Show all 9Show fewer
- Radiation therapy in head and neck region
- HIV, TB, hepatitis or other infectious diseases
- Drug and alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Awareness of Dental Implant Care and Its Correlation With Oral Hygiene Practices and the Presence of Peri-Implant Diseases
Objective: This study investigated how patients' knowledge, attitude, and perceptions influence their oral hygiene practices as well as peri-implant health. Materials and Methods: Participants with single implant crowns placed in 2007-2011 completed a questionnaire that examined their knowledge, attitude, and perceptions on oral hygiene practices and peri-implant health before receiving a periodontal examination, prophylaxis, and oral hygiene education. Clinical parameters recorded were peri-implant probing depths and plaque index, width of keratinized mucosa, implant crown characteristics, reason for tooth loss, and diagnosis of peri-implant health.
Read the detailed description
First, a trained clinical research dental assistant interviewed the participants and showed them pictures of oral hygiene aids so that the participants could answer the survey questions accurately. Subsequently, a periodontal examination, dental prophylaxis, and oral hygiene education were performed. Participants with active diseases e.g. caries, periodontitis, or peri-implantitis were referred for further management. The following clinical parameters were recorded during the examination:
- Probing depths at 6 sites around the implant (mesiobuccal, midbuccal, distobuccal, distolingual, midlingual and mesiolingual)
- Plaque index (Silness \& Loe 1964) at 4 sites around the implant (mesial, buccal, distal and lingual)
- Amount of keratinized mucosa at the implant site
- Characteristics of the implant crown:
- Type of implant crown (screw- or cement-retained) and
- Position of crown margins (supra-, equi- or sub-gingival)
- Reason(s) for tooth loss
- Diagnosis of peri-implant health
- Normal
- Mucositis, defined as 3 or more bleeding points per implant
- Peri-implantitis, defined as implant thread exposure that was either clinically visible or detectable with a periodontal probe.
- Conditions
- Peri-implant Mucositis, Peri-Implantitis, Dental Plaque
- Being tested
- non-surgical periodontal treatment
- Keywords
- Dental devices, Home care, Awareness, Peri-implant mucositis, Peri-implantitis
- Medical subject headings
- Peri-Implantitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-surgical periodontal treatmentProcedure or surgery
scaling, root planing, polishing, and oral hygiene education was performed
What is being measured
The primary outcome is the main question the study is designed to answer.
qualitative assessment of patient's knowledge on care and maintenance of dental implants using a questionnaire based on a 5 point Likert scale
patient's knowledge of peri-implant diseases
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start1 Apr 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Health System, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Hui Fu, National University Health System, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497065
- Sponsor's protocol ID
- 2017/00027
- Other IDs
- 2017
- Status last verified
- Apr 2018
- First submitted
- 30 Mar 2018
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness of Dental Implant Care and Its Correlation With Oral Hygiene Practices and the Presence of Peri-Implant Diseases
- ClinicalTrials.gov ID
- NCT03497065
- Acronym / sponsor ID
- 2017/00027
- Conditions
- Peri-implant Mucositis, Peri-Implantitis, Dental Plaque
- Keywords
- Dental devices, Home care, Awareness, Peri-implant mucositis, Peri-implantitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 13 Apr 2018 (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.
Objective: This study investigated how patients' knowledge, attitude, and perceptions influence their oral hygiene practices as well as peri-implant health. Materials and Methods: Participants with single implant crowns placed in 2007-2011 completed a questionnaire that examined their knowledge, attitude, and perceptions on oral hygiene practices and peri-implant health before receiving a periodontal examination, prophylaxis, and oral hygiene education. Clinical parameters recorded were peri-implant probing depths and plaque index, width of keratinized mucosa, implant crown characteristics, reason for tooth loss, and diagnosis of peri-implant health.
Detailed description
First, a trained clinical research dental assistant interviewed the participants and showed them pictures of oral hygiene aids so that the participants could answer the survey questions accurately. Subsequently, a periodontal examination, dental prophylaxis, and oral hygiene education were performed. Participants with active diseases e.g. caries, periodontitis, or peri-implantitis were referred for further management. The following clinical parameters were recorded during the examination:
- Probing depths at 6 sites around the implant (mesiobuccal, midbuccal, distobuccal, distolingual, midlingual and mesiolingual)
- Plaque index (Silness \& Loe 1964) at 4 sites around the implant (mesial, buccal, distal and lingual)
- Amount of keratinized mucosa at the implant site
- Characteristics of the implant crown:
- Type of implant crown (screw- or cement-retained) and
- Position of crown margins (supra-, equi- or sub-gingival)
- Reason(s) for tooth loss
- Diagnosis of peri-implant health
- Normal
- Mucositis, defined as 3 or more bleeding points per implant
- Peri-implantitis, defined as implant thread exposure that was either clinically visible or detectable with a periodontal probe.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is made up 50.6% male and 49.4% female, mainly Chinese (87.3%), Indian (5%), Malay (3.8%), Caucasian (1.3%), Eurasian (1.3%), and Japanese (1.3%), with a mean age of 58.6 years old.
Key inclusion criteria (3 listed)
- English speaking patient
- Aged 21 years old or above
- Received at least 1 implant-supported single crown from NUH in the year 2007-2011 (in functional loading for at least 5 years)
Key exclusion criteria (9 listed)
- Implant is used to restore overdentures or multi-unit restorations such as splinted crowns, fixed partial dentures, and cantilevers.
- Pregnant/lactating women
- Parkinson's disease or any other debilitating diseases
- Physical or mental disabilities that may impair oral hygiene practices
- Poorly controlled diabetes
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 |
|---|---|---|
| non-surgical periodontal treatmentscaling, root planing, polishing, and oral hygiene education was performed | Procedure or surgery | – |
Primary outcome
qualitative assessment of patient's knowledge on care and maintenance of dental implants using a questionnaire based on a 5 point Likert scale
Time frame: 1 day
patient's knowledge of peri-implant diseases
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 13 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Peri-implant Mucositis
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Not yet recruiting
Adjunctive Diode Laser Therapy for Peri-Implant Mucositis
Peri-implant Mucositis
Not yet recruitingObservational study
Short Versus Standard Dental Implants: Clinical and Biomarker Outcomes
Peri-Implant Mucositis
RecruitingObservational study
Impact of Smoking on Immune Responses in Peri-implant Health and Disease
Peri-Implant Health, Peri Implant Mucositis
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-implant Mucositis and Peri-Implantitis, run by National University Health System, Singapore at 1 site in Singapore.
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 3 inclusion and 9 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 13 Apr 2018. 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 Singapore. 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?
qualitative assessment of patient's knowledge on care and maintenance of dental implants using a questionnaire based on a 5 point Likert scale (time frame: 1 day). 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 13 Apr 2018.