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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03497065
Other study ID # 2017/00027
Secondary ID
Status Completed
Phase
First received March 30, 2018
Last updated April 5, 2018
Start date April 1, 2017
Est. completion date September 30, 2017

Study information

Verified date April 2018
Source National University Health System, Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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:

1. Probing depths at 6 sites around the implant (mesiobuccal, midbuccal, distobuccal, distolingual, midlingual and mesiolingual)

2. Plaque index (Silness & Loe 1964) at 4 sites around the implant (mesial, buccal, distal and lingual)

3. Amount of keratinized mucosa at the implant site

4. Characteristics of the implant crown:

- Type of implant crown (screw- or cement-retained) and

- Position of crown margins (supra-, equi- or sub-gingival)

5. Reason(s) for tooth loss

6. 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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date September 30, 2017
Est. primary completion date September 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 80 Years
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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)

- Radiation therapy in head and neck region

- HIV, TB, hepatitis or other infectious diseases

- Drug and alcohol abuse

Study Design


Intervention

Procedure:
non-surgical periodontal treatment
scaling, root planing, polishing, and oral hygiene education was performed

Locations

Country Name City State
Singapore National University Hospital Singapore

Sponsors (1)

Lead Sponsor Collaborator
National University Health System, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 day
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