Clinical trial NCT03960281: Assessment of Esthetics and Patient-reported Outcomes of Single Implant Crowns
Official title: Retrospective Assessment of Esthetics and Patient-reported Outcomes of Single Implant Crowns
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pink and White Esthetic Scores
Patient Outcome Measures
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Presence of active infection around the implant
* Presence of active periodontal disease in the esthetic area.
* Opposing removable prosthesis

Primary outcomes:
measure: PES/WES scores of single implant crowns in the anterior maxilla
timeFrame: the single implant crown should be "1 year" to "15 years" in function
measure: OHIP questionnaire patient reported outcome
timeFrame: the single implant crown should be "1 year" to "15 years" in function
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Brennan 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.
citation: Insua 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.
citation: Furhauser 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.
citation: Buser 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.
citation: Al 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.