Pink and White Esthetic ScoresNCT03960281
Assessment of Esthetics and Patient-reported Outcomes of Single Implant Crowns
An observational study of Pink and White Esthetic Scores and Patient Outcome Measures, run by University of Jordan.
Trial summary
The aim of this retrospective study is to perform an assessment of esthetic outcomes of single implants and obtain patient reported outcome measures through the use of a satisfaction questionnaire and the OHIP-14 (Oral Health Impact Profile) questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pink and White Esthetic Scores, Patient Outcome Measures
- What is being tested?
- Regular dental examination
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Feb 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
- Adult, Older adult
Study population: Patients who had a single implant crown placed more than one year ago in the anterior maxilla (second premolar to second premolar) who fit the inclusion criteria
Who may be able to join
- Patients 18 years or older
- Good oral hygiene
- Single implant crown in the esthetic zone (maxillary 2nd premolar to 2nd premolar)
- Implant crown surrounded by natural teeth
- Implant crown opposed by natural dentition or fixed prostheses
- Implant crown has been installed for at least one year
Who cannot join
- Presence of active infection around the implant
- Presence of active periodontal disease in the esthetic area.
- Opposing removable prosthesis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Retrospective Assessment of Esthetics and Patient-reported Outcomes of Single Implant Crowns
The aim of this retrospective study is to perform an assessment of esthetic outcomes of single implants and obtain patient reported outcome measures through the use of a satisfaction questionnaire and the OHIP-14 (Oral Health Impact Profile) questionnaire. Dentists will be performing clinical examination including teeth charting and periodontal charting as well as pink/white esthetic score assessment and these outcomes will be compared to the level of patient satisfaction and patient reported outcomes. The results of this research will add evidence-based data on treatment recommendations for teeth replacement with implants from a patient-centered perspective.
- Being tested
- Regular dental examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular dental examinationOther
Regular dental examination, and the patient will be asked to fill a questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Single implant crowns in the anterior maxilla | No drugs to be administered. Patients who have had a single implant crown placed since more than one year in the anterior maxilla (second premolar to second premolar) will be invited for a review session for dental examination and to fill the Oral Health Impact Profile (OHIP) questionnaire. Receives: Other: Regular dental examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
PES/WES scores of single implant crowns in the anterior maxilla
Assessment of pink esthetic score/white esthetic score (PES/WES) scores for implant supported prostheses
Measured: the single implant crown should be "1 year" to "15 years" in function
OHIP questionnaire patient reported outcome
Assessment of patient reported satisfaction with esthetics of implant supported single crowns
Measured: the single implant crown should be "1 year" to "15 years" in function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study startJun 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pink and White Esthetic ScoresStudies 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
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra AlTarawneh, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960281
- Sponsor's protocol ID
- 2019/182
- Status last verified
- May 2019
- First submitted
- 15 May 2019
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Box VH, Sukotjo C, Knoernschild KL, Campbell SD, Afshari FS. Patient-Reported and Clinical Outcomes of Implant-Supported Fixed Complete Dental Prostheses: A Comparison of Metal-Acrylic, Milled Zirconia, and Retrievable Crown Prostheses. J Oral Implantol. 2018 Feb;44(1):51-61. doi: 10.1563/aaid-joi-D-17-00184. Epub 2017 Nov 1.
PubMed 29091015Brennan M, Houston F, O'Sullivan M, O'Connell B. Patient satisfaction and oral health-related quality of life outcomes of implant overdentures and fixed complete dentures. Int J Oral Maxillofac Implants. 2010 Jul-Aug;25(4):791-800.
PubMed 20657876Insua A, Monje A, Wang HL, Inglehart M. Patient-Centered Perspectives and Understanding of Peri-Implantitis. J Periodontol. 2017 Nov;88(11):1153-1162. doi: 10.1902/jop.2017.160796. Epub 2017 May 26.
PubMed 28548884Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
PubMed 16307569Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants. 2004;19 Suppl:43-61.
PubMed 15635945Al Habashneh R, Khader YS, Salameh S. Use of the Arabic version of Oral Health Impact Profile-14 to evaluate the impact of periodontal disease on oral health-related quality of life among Jordanian adults. J Oral Sci. 2012 Mar;54(1):113-20. doi: 10.2334/josnusd.54.113.
PubMed 22466895
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Assessment of Esthetics and Patient-reported Outcomes of Single Implant Crowns
- ClinicalTrials.gov ID
- NCT03960281
- Acronym / sponsor ID
- 2019/182
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 23 May 2019 (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 retrospective study is to perform an assessment of esthetic outcomes of single implants and obtain patient reported outcome measures through the use of a satisfaction questionnaire and the OHIP-14 (Oral Health Impact Profile) questionnaire. Dentists will be performing clinical examination including teeth charting and periodontal charting as well as pink/white esthetic score assessment and these outcomes will be compared to the level of patient satisfaction and patient reported outcomes. The results of this research will add evidence-based data on treatment recommendations for teeth replacement with implants from a patient-centered perspective.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single implant crowns in the anterior maxilla | – | Other: Regular dental examinationNo drugs to be administered. Patients who have had a single implant crown placed since more than one year in the anterior maxilla (second premolar to second premolar) will be invited for a review session for dental examination and to fill the Oral Health Impact Profile (OHIP) questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who had a single implant crown placed more than one year ago in the anterior maxilla (second premolar to second premolar) who fit the inclusion criteria
Key inclusion criteria (6 listed)
- Patients 18 years or older
- Good oral hygiene
- Single implant crown in the esthetic zone (maxillary 2nd premolar to 2nd premolar)
- Implant crown surrounded by natural teeth
- Implant crown opposed by natural dentition or fixed prostheses
Key exclusion criteria (3 listed)
- Presence of active infection around the implant
- Presence of active periodontal disease in the esthetic area.
- Opposing removable prosthesis
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 |
|---|---|---|
| Regular dental examinationRegular dental examination, and the patient will be asked to fill a questionnaire | Other | Single implant crowns in the anterior maxilla |
Primary outcome
PES/WES scores of single implant crowns in the anterior maxilla
Time frame: the single implant crown should be "1 year" to "15 years" in function
Assessment of pink esthetic score/white esthetic score (PES/WES) scores for implant supported prostheses
OHIP questionnaire patient reported outcome
Time frame: the single implant crown should be "1 year" to "15 years" in function
Assessment of patient reported satisfaction with esthetics of implant supported single crowns
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Background: PubMed 29091015Box VH, Sukotjo C, Knoernschild KL, Campbell SD, Afshari FS. Patient-Reported and Clinical Outcomes of Implant-Supported Fixed Complete Dental Prostheses: A Comparison of Metal-Acrylic, Milled Zirconia, and Retrievable Crown Prostheses. J Oral Implantol. 2018 Feb;44(1):51-61. doi: 10.1563/aaid-joi-D-17-00184. Epub 2017 Nov 1.
- Background: PubMed 20657876Brennan M, Houston F, O'Sullivan M, O'Connell B. Patient satisfaction and oral health-related quality of life outcomes of implant overdentures and fixed complete dentures. Int J Oral Maxillofac Implants. 2010 Jul-Aug;25(4):791-800.
- Background: PubMed 28548884Insua A, Monje A, Wang HL, Inglehart M. Patient-Centered Perspectives and Understanding of Peri-Implantitis. J Periodontol. 2017 Nov;88(11):1153-1162. doi: 10.1902/jop.2017.160796. Epub 2017 May 26.
- Background: PubMed 16307569Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
- Background: PubMed 15635945Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants. 2004;19 Suppl:43-61.
- Background: PubMed 22466895Al Habashneh R, Khader YS, Salameh S. Use of the Arabic version of Oral Health Impact Profile-14 to evaluate the impact of periodontal disease on oral health-related quality of life among Jordanian adults. J Oral Sci. 2012 Mar;54(1):113-20. doi: 10.2334/josnusd.54.113.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pink and White Esthetic Scores and Patient Outcome Measures, run by University of Jordan.
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 6 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: status not confirmed, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Sandra AlTarawneh, MSc (0096265355000, s_altarawneh@ju.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PES/WES scores of single implant crowns in the anterior maxilla (time frame: the single implant crown should be "1 year" to "15 years" in function). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03960281, which also lists 6 linked publications.
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 24 May 2019.