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

NCT05424458 | Completed DMC

• 1 other identifier: KQEC-2021-46-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

dental anxiety; aesthetic perception; oral health-related quality of life; anterior implant treatment

Outcome Measures

Primary Outcomes (3)

• 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.).

  Before implant surgery and in the first month after definitive prosthesis placement

• 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').

  Before implant surgery and in the first month after definitive prosthesis placement

• 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).

  Before implant surgery and in the first month after definitive prosthesis placement

Study Arms (1)

single-arm

EXPERIMENTAL

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.

Procedure: Anterior Implant Treatment

Interventions

Anterior Implant Treatment PROCEDURE

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.

single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Feilong Deng: lead

Study Sites (1)

Hospital of Stomatology, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (11)

• 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.

  PMID: 29478284 BACKGROUND

• 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.

  PMID: 33446161 BACKGROUND

• 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.

  PMID: 31025495 BACKGROUND

• 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.

  PMID: 26968266 BACKGROUND

• 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.

  PMID: 25294397 BACKGROUND

• 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.

  PMID: 28708923 BACKGROUND

• 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.

  PMID: 32589000 BACKGROUND

• 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.

  PMID: 34625591 BACKGROUND

• 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.

  PMID: 30537968 BACKGROUND

• 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.

  PMID: 34866250 BACKGROUND

• Xie X, Zhang Z, Zhou J, Deng F. Changes of dental anxiety, aesthetic perception and oral health-related quality of life related to influencing factors of patients' demographics after anterior implant treatment: a prospective study. Int J Implant Dent. 2023 Aug 2;9(1):22. doi: 10.1186/s40729-023-00486-y.

  PMID: 37530855 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 21, 2022
• Study Start: August 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: April 30, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data may be available once published within one year.
• Access Criteria: Sun Yat sen University RDD platform once the data are published.

Locations

CN (1)