Dental AnxietyNCT05424458
Effect of Anterior Implant Treatment on DA, Aesthetic Perception and OHRQoL Changes
A study testing Anterior Implant Treatment in people with Dental Anxiety and Aesthetic Perception, run by Feilong Deng at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Anxiety, Aesthetic Perception, Oral Health-related Quality of Life
- What is being tested?
- Anterior Implant Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 30 Apr 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Hospital of Stomatology, Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
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
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.
Read the 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.
- Being tested
- Anterior Implant Treatment
- Keywords
- dental anxiety, aesthetic perception, oral health-related quality of life, anterior implant treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Implant TreatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Anterior Implant Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.).
Measured: 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').
Measured: 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).
Measured: Before implant surgery and in the first month after definitive prosthesis placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Aug 2021
- Primary completion31 Dec 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Feilong Deng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feilong Deng, Hospital of Stomatology, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424458
- Sponsor's protocol ID
- KQEC-2021-46-01
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes
Publications
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.
PubMed 29478284Wang 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.
PubMed 33446161Zhang 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.
PubMed 31025495Yoshida 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.
PubMed 26968266Persic 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.
PubMed 25294397Bovaira 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.
PubMed 28708923Elfadil 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.
PubMed 32589000Sanchez-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.
PubMed 34625591Bersezio 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.
PubMed 30537968Nielsen 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.
PubMed 34866250Xie 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.
PubMed 37530855
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05424458
- Acronym / sponsor ID
- KQEC-2021-46-01
- Keywords
- dental anxiety, aesthetic perception, oral health-related quality of life, anterior implant treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Feilong DengUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 21 Jun 2022 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| single-arm | Experimental | Procedure: Anterior Implant TreatmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Anterior Implant TreatmentPatients 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. | Procedure or surgery | single-arm |
Primary outcome
Changes of the modified dental anxiety scale (MDAS) before and after anterior implant treatment
Time frame: Before implant surgery and in the first month after definitive prosthesis placement
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
Time frame: Before implant surgery and in the first month after definitive prosthesis placement
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
Time frame: Before implant surgery and in the first month after definitive prosthesis placement
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Background: PubMed 29478284Kan 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.
- Background: PubMed 33446161Wang 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.
- Background: PubMed 31025495Zhang 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.
- Background: PubMed 26968266Yoshida 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.
- Background: PubMed 25294397Persic 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.
- Background: PubMed 28708923Bovaira 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.
- Background: PubMed 32589000Elfadil 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.
- Background: PubMed 34625591Sanchez-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.
- Background: PubMed 30537968Bersezio 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.
- Background: PubMed 34866250Nielsen 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.
- Derived from this study: PubMed 37530855Xie 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.
- Individual participant dataSharing planned: Yes. Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Implant Treatment in people with Dental Anxiety and Aesthetic Perception, run by Feilong Deng at 1 site in China.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the modified dental anxiety scale (MDAS) before and after anterior implant treatment (time frame: Before implant surgery and in the first month after definitive prosthesis placement). The study lists 3 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 NCT05424458, which also lists 11 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 21 Jun 2022.