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Effect of Anterior Implant Treatment on DA, Aesthetic Perception and OHRQoL Changes

Primary Purpose

Dental Anxiety, Aesthetic Perception, Oral Health-related Quality of Life

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anterior Implant Treatment
Sponsored by
Feilong Deng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dental Anxiety focused on measuring dental anxiety, aesthetic perception, oral health-related quality of life, anterior implant treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age≥18 years old
  • partially anterior edentulous jaws
  • patients will be given an anterior implant surgery and implant-supported fixed rehabilitation
  • patients could express themselves and communicate normally
  • willing to participate in and accept investigation

Exclusion Criteria:

  • use of anti-anxiety and painkillers within 1 year
  • mental and psychological diseases with poor emotional self-control
  • a history of previous implant loss
  • ongoing active infections by endodontic or periodontal problems of all the remaining teeth
  • combined complex surgery including maxillary sinus augumentation, and large-block autogenous bone grafting

Sites / Locations

  • Hospital of Stomatology, Sun Yat-sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single-arm

Arm Description

Patients received routine examinations before surgery. The surgical procedures were performed by experienced experts. Immediate loading protocol was delivered if the insertion torque was over 35 N·cm; otherwise, removable restorations with submerged implants were applied. After a healing period of 3 to 6 months, a definitive screw-retained porcelain-fused-to-metal (PFM) or a CAD/CAM zirconia restoration were performed. In the first month after definitive prosthesis placement, patients were recalled to complete the MDAS, OES and OHIP questionnaires for the second time. Changes of overall MDAS, OSE and OHIP score were defined as the score after definitive prosthesis placement minus that before the treatment. Negative score changes indicated score decrease of the second questionnaire compared to the first one. Positive score changes indicated score increase.

Outcomes

Primary Outcome Measures

Changes of the modified dental anxiety scale (MDAS) before and after anterior implant treatment
Dental anxiety levels changes between two time points. The modified dental anxiety scale (MDAS) included five questions with a 5-category scale, ranging from 'not' to 'extremely'. On MDAS questionnaire numbers correspond to the dimensions (1 = Not, 2 = Slightly, 3 = Fairly, 4 = Very, 5 = Extremely. Overall MDAS score: Q1-Q5 summary score.).
Changes of the Orofacial Esthetics Scale (OES) before and after anterior implant treatment
Aesthetic perception changes changes between two time points. The Orofacial Esthetics Scale (OES) is a scale that was designed by 8 items to evaluate the self-perception of aesthetic implant treatment (Ranged from 0 to 10 scores, 0 is 'Very dissatisfied' and 10 is 'Very satisfied').
Changes of the Oral Health Impact Profile (OHIP) before and after anterior implant treatment
Oral health-related quality of life changes between two time points. The Oral Health Impact Profile (OHIP) is to measure OHRQoL, comprising 14 statements with 5 scores (1 = Not, 2 = Seldom, 3 = Sometimes, 4 = Often, 5 = Very often; total scores: 14-70).

Secondary Outcome Measures

Full Information

First Posted
June 13, 2022
Last Updated
June 15, 2022
Sponsor
Feilong Deng
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1. Study Identification

Unique Protocol Identification Number
NCT05424458
Brief Title
Effect of Anterior Implant Treatment on DA, Aesthetic Perception and OHRQoL Changes
Official Title
Changes of Dental Anxiety, Aesthetic Perception and Oral Health-related Quality of Life Related to Influencing Factors of Patients' Demographics After Anterior Implant Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Feilong Deng

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Accumulating evidence has revealed the effects of anterior implant procedures on dental anxiety (DA), aesthetic perception and oral health-related quality of life (OHRQoL). However, few reported the changes and influencing factors of the above outcomes before and after anterior implant treatment. The aim of this study was to evaluate the changes of DA, aesthetic perception and OHRQoL related to influencing factors of patients' demographics after anterior implant treatment.
Detailed Description
The purpose of this prospective study was to evaluate the changes of DA, aesthetic perception and OHRQoL related to influencing factors of patients' age, gender and educational status after anterior implant treatment. The subjects (n=39) included in this prospective study were recruited from those patients with anterior missing teeth at the Department of Oral Implantology, Guanghua School of Stomatology, Sun Yat-sen University. Patients satisfying the following inclusion criteria were recruited: (1) age≥18 years old; (2) partially anterior edentulous jaws; (3) patients will be given an anterior implant surgery and implant-supported fixed rehabilitation; (4) patients could express themselves and communicate normally; (4) willing to participate in and accept investigation. Exclusion criteria were (1) use of anti-anxiety and painkillers within 1 year.; (2) mental and psychological diseases with poor emotional self-control; (3) a history of previous implant loss; (4) ongoing active infections by endodontic or periodontal problems of all the remaining teeth; (5) combined complex surgery including maxillary sinus augumentation, and large-block autogenous bone grafting. Before implant surgery, all participants signed an informed consent form and were given sufficient time in the waiting room to answer the following three scales. The modified dental anxiety scale (MDAS) included five questions with a 5-category scale, ranging from 'not' to 'extremely'. The Orofacial Esthetics Scale (OES) is a scale that was designed by 8 items to evaluate the self-perception of aesthetic implant treatment (Ranged from 0 to 10 scores, 0 is 'Very dissatisfied' and 10 is 'Very satisfied'). The Oral Health Impact Profile (OHIP) is to measure OHRQoL, comprising 14 statements with 5 scores (1 = Not, 2 = Seldom, 3 = Sometimes, 4 = Often, 5 = Very often; total scores: 14-70). Influencing factors of patients' demographics including age, gender and educational status were obtained from the medical records. Patients received routine examinations before surgery. The surgical procedures were performed by experienced experts. Immediate loading protocol was delivered if the insertion torque was over 35 N·cm; otherwise, removable restorations with submerged implants were applied. After a healing period of 3 to 6 months, a definitive screw-retained porcelain-fused-to-metal (PFM) or a CAD/CAM zirconia restoration were performed. In the first month after definitive prosthesis placement, patients were recalled to complete the MDAS, OES and OHIP questionnaires for the second time. Changes of overall MDAS, OSE and OHIP score were defined as the score after definitive prosthesis placement minus that before the treatment. Negative score changes indicated score decrease of the second questionnaire compared to the first one. Positive score changes indicated score increase. Data were collected and evaluated from the scales by two independent researchers. Data were calculated by descriptive statistics (mean, standard deviation) and were analyzed using the SPSS 25.0 software package (SPSS Inc., USA). Mann-Whitney U test was used to determine the score change before and after anterior implant treatment. Mann-Whitney U test (gender) and Kruskal-Wallis test by Bonferroni correction (age and educational status) were applied for the influencing factors evaluation based on the changes of overall MDAS, OSE and OHIP score. The level of significance was set at p < 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety, Aesthetic Perception, Oral Health-related Quality of Life
Keywords
dental anxiety, aesthetic perception, oral health-related quality of life, anterior implant treatment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
The subjects completed the Modified Dental Anxiety Scale (MDAS), the Orofacial Esthetic Scale (OSE) and the Oral Health Impact Profile-14 (OHIP-14), before implant surgery and after definitive prosthesis placement.
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single-arm
Arm Type
Experimental
Arm Description
Patients received routine examinations before surgery. The surgical procedures were performed by experienced experts. Immediate loading protocol was delivered if the insertion torque was over 35 N·cm; otherwise, removable restorations with submerged implants were applied. After a healing period of 3 to 6 months, a definitive screw-retained porcelain-fused-to-metal (PFM) or a CAD/CAM zirconia restoration were performed. In the first month after definitive prosthesis placement, patients were recalled to complete the MDAS, OES and OHIP questionnaires for the second time. Changes of overall MDAS, OSE and OHIP score were defined as the score after definitive prosthesis placement minus that before the treatment. Negative score changes indicated score decrease of the second questionnaire compared to the first one. Positive score changes indicated score increase.
Intervention Type
Procedure
Intervention Name(s)
Anterior Implant Treatment
Intervention Description
Patients received routine examinations before surgery. The surgical procedures were performed by experienced experts. Immediate loading protocol was delivered if the insertion torque was over 35 N·cm; otherwise, removable restorations with submerged implants were applied. After a healing period of 3 to 6 months, a definitive screw-retained porcelain-fused-to-metal (PFM) or a CAD/CAM zirconia restoration were performed.
Primary Outcome Measure Information:
Title
Changes of the modified dental anxiety scale (MDAS) before and after anterior implant treatment
Description
Dental anxiety levels changes between two time points. The modified dental anxiety scale (MDAS) included five questions with a 5-category scale, ranging from 'not' to 'extremely'. On MDAS questionnaire numbers correspond to the dimensions (1 = Not, 2 = Slightly, 3 = Fairly, 4 = Very, 5 = Extremely. Overall MDAS score: Q1-Q5 summary score.).
Time Frame
Before implant surgery and in the first month after definitive prosthesis placement
Title
Changes of the Orofacial Esthetics Scale (OES) before and after anterior implant treatment
Description
Aesthetic perception changes changes between two time points. The Orofacial Esthetics Scale (OES) is a scale that was designed by 8 items to evaluate the self-perception of aesthetic implant treatment (Ranged from 0 to 10 scores, 0 is 'Very dissatisfied' and 10 is 'Very satisfied').
Time Frame
Before implant surgery and in the first month after definitive prosthesis placement
Title
Changes of the Oral Health Impact Profile (OHIP) before and after anterior implant treatment
Description
Oral health-related quality of life changes between two time points. The Oral Health Impact Profile (OHIP) is to measure OHRQoL, comprising 14 statements with 5 scores (1 = Not, 2 = Seldom, 3 = Sometimes, 4 = Often, 5 = Very often; total scores: 14-70).
Time Frame
Before implant surgery and in the first month after definitive prosthesis placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age≥18 years old partially anterior edentulous jaws patients will be given an anterior implant surgery and implant-supported fixed rehabilitation patients could express themselves and communicate normally willing to participate in and accept investigation Exclusion Criteria: use of anti-anxiety and painkillers within 1 year mental and psychological diseases with poor emotional self-control a history of previous implant loss ongoing active infections by endodontic or periodontal problems of all the remaining teeth combined complex surgery including maxillary sinus augumentation, and large-block autogenous bone grafting
Facility Information:
Facility Name
Hospital of Stomatology, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Yes
IPD Sharing Time Frame
The data may be available once published within one year.
IPD Sharing Access Criteria
Sun Yat sen University RDD platform once the data are published.
Citations:
PubMed Identifier
29478284
Citation
Kan JYK, Rungcharassaeng K, Deflorian M, Weinstein T, Wang HL, Testori T. Immediate implant placement and provisionalization of maxillary anterior single implants. Periodontol 2000. 2018 Jun;77(1):197-212. doi: 10.1111/prd.12212. Epub 2018 Feb 25.
Results Reference
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PubMed Identifier
33446161
Citation
Wang Y, Baumer D, Ozga AK, Korner G, Baumer A. Patient satisfaction and oral health-related quality of life 10 years after implant placement. BMC Oral Health. 2021 Jan 14;21(1):30. doi: 10.1186/s12903-020-01381-3.
Results Reference
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PubMed Identifier
31025495
Citation
Zhang X, Wang B, Qiao SC, Gu YX, Shi JY, Lai HC. A study on the prevalence of dental anxiety, pain perception, and their interrelationship in Chinese patients with oral implant surgery. Clin Implant Dent Relat Res. 2019 Jun;21(3):428-435. doi: 10.1111/cid.12779. Epub 2019 Apr 26.
Results Reference
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PubMed Identifier
26968266
Citation
Yoshida T, Masaki C, Komai H, Misumi S, Mukaibo T, Kondo Y, Nakamoto T, Hosokawa R. Changes in oral health-related quality of life during implant treatment in partially edentulous patients: A prospective study. J Prosthodont Res. 2016 Oct;60(4):258-264. doi: 10.1016/j.jpor.2016.01.010. Epub 2016 Mar 8.
Results Reference
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PubMed Identifier
25294397
Citation
Persic S, Celebic A. Influence of different prosthodontic rehabilitation options on oral health-related quality of life, orofacial esthetics and chewing function based on patient-reported outcomes. Qual Life Res. 2015 Apr;24(4):919-26. doi: 10.1007/s11136-014-0817-2. Epub 2014 Oct 8.
Results Reference
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PubMed Identifier
28708923
Citation
Bovaira M, Herrero Babiloni A, Jovani M, Penarrocha-Diago M, Gonzalez-Lemonnier S, Penarrocha-Oltra D. Preoperative Anxiety and Its Influence on Patient and Surgeon Satisfaction in Patients Receiving Dental Implant Surgeries Performed Under Intravenous Conscious Sedation. Int J Oral Maxillofac Implants. 2017 Jul/Aug;32(4):912-918. doi: 10.11607/jomi.5712.
Results Reference
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PubMed Identifier
32589000
Citation
Elfadil S, Johnston B, Normand C, Allen F, O'Connell B. An Investigation of the Characteristics of Edentulous Patients Who Choose or Refuse Implant Treatment. Int J Prosthodont. 2021 March/April;34(2):147-153. doi: 10.11607/ijp.6222. Epub 2020 Jun 26.
Results Reference
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PubMed Identifier
34625591
Citation
Sanchez-Perez A, Nicolas-Silvente AI, Sanchez-Matas C, Molina-Garcia S, Navarro-Cuellar C, Romanos GE. Primary stability and PES/WES evaluation for immediate implants in the aesthetic zone: a pilot clinical double-blind randomized study. Sci Rep. 2021 Oct 8;11(1):20024. doi: 10.1038/s41598-021-99218-8.
Results Reference
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Bersezio C, Martin J, Herrera A, Loguercio A, Fernandez E. The effects of at-home whitening on patients' oral health, psychology, and aesthetic perception. BMC Oral Health. 2018 Dec 11;18(1):208. doi: 10.1186/s12903-018-0668-2.
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Nielsen HB, Schou S, Bruun NH, Starch-Jensen T. Professional and patient-reported outcomes of two surgical approaches for implant-supported single-crown restoration: 1-year results of a randomized controlled clinical trial. Clin Oral Implants Res. 2022 Feb;33(2):197-208. doi: 10.1111/clr.13883. Epub 2021 Dec 17.
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Effect of Anterior Implant Treatment on DA, Aesthetic Perception and OHRQoL Changes

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