Clinical trial NCT05424458: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Hospital of Stomatology, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Changes of the modified dental anxiety scale (MDAS) before and after anterior implant treatment
timeFrame: Before implant surgery and in the first month after definitive prosthesis placement
measure: Changes of the Orofacial Esthetics Scale (OES) before and after anterior implant treatment
timeFrame: Before implant surgery and in the first month after definitive prosthesis placement
measure: Changes of the Oral Health Impact Profile (OHIP) before and after anterior implant treatment
timeFrame: Before implant surgery and in the first month after definitive prosthesis placement
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hospital of Stomatology, Sun Yat-sen University
state: Guangdong
Study officials:
References:
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