Dental ImplantationNCT04950491
Patient-reported Outcome Measures Comparing Static Computer-aided Implant Surgery and Conventional Implant Surgery
A study testing Modified Dental Anxiety Score (MDAS) questionnaire, Pain questionnaire and Oral Health-Related Quality of Life (OHRQoL) questionnaire in people with Dental Implantation and Postoperative Pain, run by Mahidol University at 1 site in Thailand.
Trial summary
The aim of this randomized controlled trial was to compare PROMs in patients receiving single tooth replacement in posterior sites by s-CAIS and CIS. Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implantation, Postoperative Pain, Computer-assisted Surgery
- What is being tested?
- Modified Dental Anxiety Score (MDAS) questionnaire, Pain questionnaire and Oral Health-Related Quality of Life (OHRQoL) questionnaire
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 9 Jul 2019to 11 Mar 2021
- 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 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy or well-controlled systemic disease (ASA classification I,II)
- A partially edentulous ridge in the premolar-molar region with existing two-sided interproximal as well as antagonist contacts
- No sign of acute oral infection
- Periodontally healthy (or successfully treated)
- More than 2 mm of keratinized gingiva at the site of surgery
- Sufficient bony ridge for implant placement with or without simultaneous bone grafting
Who cannot join
- Diabetes mellitus
- Smoking more than ten cigarettes per day
- Pregnancy
- Psychiatric disorder
- History of radiation therapy at head and neck area and chemotherapy
- Bony pathologies, namely osseous dysplasia, odontogenic cyst, tumor
- History of soft tissue grafting at the prospective implant site
- Inadequate bony ridge with the need of bone augmentation prior to implant placement
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Dentistry, Mahidol University
Ratchathewi, Bangkok, 10400
About this study
Official title: Patient-reported Outcome Measures (PROMs) Comparing Static Computer-aided Implant Surgery (s-CAIS) and Conventional Implant Surgery (CIS) for Single-tooth Replacement: A Randomized Controlled Trial
The aim of this randomized controlled trial was to compare PROMs in patients receiving single tooth replacement in posterior sites by s-CAIS and CIS.
Read the detailed description
Since current patient-reported outcome measures (PROMs) evidence related to static computer-aided implant surgery (s-CAIS) compared with conventional implant surgery (CIS), particularly in partial edentulous patients, were still limited. The aim of this randomized controlled trial was to compare PROMs in patients receiving single tooth replacement in posterior sites by s-CAIS and CIS.
- Conditions
- Dental Implantation, Postoperative Pain, Computer-assisted Surgery, Patient Outcome Assessment, Dental Anxiety, Quality of Life
- Being tested
- Modified Dental Anxiety Score (MDAS) questionnaire, Pain questionnaire, Oral Health-Related Quality of Life (OHRQoL) questionnaire
- Keywords
- Clinical Research, Dental Implant, Static Computer-Aided Implant Surgery (s-CAIS), Patient-Reported Outcome Measures (PROMs), Dental Anxiety, Pain, Oral Health-Related Quality of Life (OHRQoL)
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Dental Anxiety Score (MDAS) questionnaireOther
MDAS was used to measure the patients' anxiety toward dental treatment before implant surgery (Humphris, Dyer, \&Robinson, 2009). Originally, the MDAS questionnaire included five questions answered with a 5-category Likert scale. The original MDAS questionnaire does not cover anxiety toward implant surgery. Therefore, a question enquiring about patients' feelings towards implant surgery was added.
Pain questionnaireOther
Patients were asked to describe the worst pain feeling using a standard 10 cm Visual Analog Scale (VAS) and the proportion of time spent in severe pain using a 5 category Likert scale. The number of analgesics taken per day was also asked.
Oral Health-Related Quality of Life (OHRQoL) questionnaireOther
The OHRQoL comprises 14 questions covering problems the patient may in three main categories: oral function, daily activity, and post-operative symptoms (Chaushu, Becker, Zeltser, Vasker, \& Chaushu, 2004). Patients answered using a 5-category Likert scale.
| Study group | Role | What they receive |
|---|---|---|
| Test group (s-CAIS) | Experimental | The test group workflow used a fully computer-guided implant surgical protocol. Receives: Other: Modified Dental Anxiety Score (MDAS) questionnaire; Other: Pain questionnaire; Other: Oral Health-Related Quality of Life (OHRQoL) questionnaire |
| Control group (CIS) | Other | The control group workflow used a conventional implant surgical protocol. Receives: Other: Modified Dental Anxiety Score (MDAS) questionnaire; Other: Pain questionnaire; Other: Oral Health-Related Quality of Life (OHRQoL) questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of post-operative pain for 7 days: Visual Analog Scale
Patients were asked to describe the worst post-operative pain feeling using a standard 10 cm Visual Analog Scale.
Measured: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.
Change of the proportion of time spent in severe pain for 7 days: 5-category Likert scale
Patients were asked to describe the proportion of time spent in severe pain using 5-category Likert scale (None, Low, Moderate, High, Very high).
Measured: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.
Change of the analgesics taken per day for 7 days: the number of tablets per day
Patients were asked to describe the number of analgesics taken per day.
Measured: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.
Change of Oral Health-Related Quality of Life (OHRQoL) for 7 days: 5-category Likert scale
The OHRQoL questionnaire comprises 14 questions covering problems the patient may in three main categories: oral function, daily activity, and post-operative symptoms derived from Chaushu's study (Chaushu, Becker, Zeltser, Vasker, \& Chaushu, 2004). Patients answered this questionnaire using a 5-category Likert scale (Not at all, Very little, A little, Quite a lot, Very much).
Measured: Patients were instructed to answer the OHRQoL every day for 7 days starting from the day of surgery 1 hour before bedtime.
Secondary outcomes (1)
The Modified Dental Anxiety Score (MDAS)
The MDAS was used to measure patient anxiety toward dental treatment (Humphris, Dyer, \& Robinson, 2009). The MDAS consists of five questions answered with a 5-category Likert scale, ranging from 'not anxious' to 'extremely anxious'. The original MDAS questionnaire does not cover anxiety toward implant surgery. Therefore, a question enquiring about patients' feelings towards implant surgery was added.
Measured: 1 day (Patients completed the modified MDAS once, while waiting for the surgery in the waiting room.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start9 Jul 2019
- Primary completion27 Nov 2020
- Study completion11 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- ITI Foundation
- Responsible party
- Principal investigator, Akarin Santivitoonvong, Mahidol University
- Investigators
- Chatchai Kunavisarut, DDS, Study chair, Department of Advanced General Dentistry, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950491
- Sponsor's protocol ID
- DT 071/2019
- Status last verified
- Jun 2021
- First submitted
- 23 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arisan V, Karabuda CZ, Ozdemir T. Implant surgery using bone- and mucosa-supported stereolithographic guides in totally edentulous jaws: surgical and post-operative outcomes of computer-aided vs. standard techniques. Clin Oral Implants Res. 2010 Sep;21(9):980-8. doi: 10.1111/j.1600-0501.2010.01957.x. Epub 2010 May 24.
PubMed 20497439Bielemann AM, Marcello-Machado RM, Del Bel Cury AA, Faot F. Systematic review of wound healing biomarkers in peri-implant crevicular fluid during osseointegration. Arch Oral Biol. 2018 May;89:107-128. doi: 10.1016/j.archoralbio.2018.02.013. Epub 2018 Feb 22.
PubMed 29510331Buser D, Chappuis V, Kuchler U, Bornstein MM, Wittneben JG, Buser R, Cavusoglu Y, Belser UC. Long-term stability of early implant placement with contour augmentation. J Dent Res. 2013 Dec;92(12 Suppl):176S-82S. doi: 10.1177/0022034513504949. Epub 2013 Oct 24.
PubMed 24158332Buser 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.
PubMed 15635945Calvert M, Brundage M, Jacobsen PB, Schunemann HJ, Efficace F. The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice. Health Qual Life Outcomes. 2013 Oct 29;11:184. doi: 10.1186/1477-7525-11-184.
PubMed 24168680Coolidge T, Hillstead MB, Farjo N, Weinstein P, Coldwell SE. Additional psychometric data for the Spanish Modified Dental Anxiety Scale, and psychometric data for a Spanish version of the Revised Dental Beliefs Survey. BMC Oral Health. 2010 May 13;10:12. doi: 10.1186/1472-6831-10-12.
PubMed 20465835D'haese J, Ackhurst J, Wismeijer D, De Bruyn H, Tahmaseb A. Current state of the art of computer-guided implant surgery. Periodontol 2000. 2017 Feb;73(1):121-133. doi: 10.1111/prd.12175.
PubMed 28000275De Bruyn H, Raes S, Matthys C, Cosyn J. The current use of patient-centered/reported outcomes in implant dentistry: a systematic review. Clin Oral Implants Res. 2015 Sep;26 Suppl 11:45-56. doi: 10.1111/clr.12634.
PubMed 26385620Feine J, Abou-Ayash S, Al Mardini M, de Santana RB, Bjelke-Holtermann T, Bornstein MM, Braegger U, Cao O, Cordaro L, Eycken D, Fillion M, Gebran G, Huynh-Ba G, Joda T, Levine R, Mattheos N, Oates TW, Abd-Ul-Salam H, Santosa R, Shahdad S, Storelli S, Sykaras N, Trevino Santos A, Stephanie Webersberger U, Williams MAH, Wilson TG Jr, Wismeijer D, Wittneben JG, Yao CJ, Zubiria JPV. Group 3 ITI Consensus Report: Patient-reported outcome measures associated with implant dentistry. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:270-275. doi: 10.1111/clr.13299.
PubMed 30328187Fortin T, Bosson JL, Isidori M, Blanchet E. Effect of flapless surgery on pain experienced in implant placement using an image-guided system. Int J Oral Maxillofac Implants. 2006 Mar-Apr;21(2):298-304.
PubMed 16634502Giri J, Pokharel PR, Gyawali R, Bhattarai B. Translation and Validation of Modified Dental Anxiety Scale: The Nepali Version. Int Sch Res Notices. 2017 Jan 29;2017:5495643. doi: 10.1155/2017/5495643. eCollection 2017.
PubMed 28251175Humphris G, King K. The prevalence of dental anxiety across previous distressing experiences. J Anxiety Disord. 2011 Mar;25(2):232-6. doi: 10.1016/j.janxdis.2010.09.007. Epub 2010 Sep 19.
PubMed 20952156Humphris GM, Morrison T, Lindsay SJ. The Modified Dental Anxiety Scale: validation and United Kingdom norms. Community Dent Health. 1995 Sep;12(3):143-50.
PubMed 7584581Iqbal MK, Kim S. A review of factors influencing treatment planning decisions of single-tooth implants versus preserving natural teeth with nonsurgical endodontic therapy. J Endod. 2008 May;34(5):519-29. doi: 10.1016/j.joen.2008.01.002.
PubMed 18436028Joda T, Derksen W, Wittneben JG, Kuehl S. Static computer-aided implant surgery (s-CAIS) analysing patient-reported outcome measures (PROMs), economics and surgical complications: A systematic review. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:359-373. doi: 10.1111/clr.13136.
PubMed 30328203
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcome Measures (PROMs) Comparing Static Computer-aided Implant Surgery (s-CAIS) and Conventional Implant Surgery (CIS) for Single-tooth Replacement: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04950491
- Acronym / sponsor ID
- DT 071/2019
- Conditions
- Dental Implantation, Postoperative Pain, Computer-assisted Surgery, Patient Outcome Assessment, Dental Anxiety, Quality of Life
- Keywords
- Clinical Research, Dental Implant, Static Computer-Aided Implant Surgery (s-CAIS), Patient-Reported Outcome Measures (PROMs), Dental Anxiety, Pain, Oral Health-Related Quality of Life (OHRQoL)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- ITI Foundation
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 27 Nov 2020 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 6 Jul 2021 (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.
The aim of this randomized controlled trial was to compare PROMs in patients receiving single tooth replacement in posterior sites by s-CAIS and CIS.
Detailed description
Since current patient-reported outcome measures (PROMs) evidence related to static computer-aided implant surgery (s-CAIS) compared with conventional implant surgery (CIS), particularly in partial edentulous patients, were still limited. The aim of this randomized controlled trial was to compare PROMs in patients receiving single tooth replacement in posterior sites by s-CAIS and CIS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group (s-CAIS) | Experimental | Other: Modified Dental Anxiety Score (MDAS) questionnaire, Other: Pain questionnaire, Other: Oral Health-Related Quality of Life (OHRQoL) questionnaireThe test group workflow used a fully computer-guided implant surgical protocol. |
| Control group (CIS) | Other | Other: Modified Dental Anxiety Score (MDAS) questionnaire, Other: Pain questionnaire, Other: Oral Health-Related Quality of Life (OHRQoL) questionnaireThe control group workflow used a conventional implant surgical protocol. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy or well-controlled systemic disease (ASA classification I,II)
- A partially edentulous ridge in the premolar-molar region with existing two-sided interproximal as well as antagonist contacts
- No sign of acute oral infection
- Periodontally healthy (or successfully treated)
- More than 2 mm of keratinized gingiva at the site of surgery
Key exclusion criteria (8 listed)
- Diabetes mellitus
- Smoking more than ten cigarettes per day
- Pregnancy
- Psychiatric disorder
- History of radiation therapy at head and neck area and chemotherapy
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 |
|---|---|---|
| Modified Dental Anxiety Score (MDAS) questionnaireMDAS was used to measure the patients' anxiety toward dental treatment before implant surgery (Humphris, Dyer, \&Robinson, 2009). Originally, the MDAS questionnaire included five questions answered with a 5-category Likert scale. The original MDAS questionnaire does not cover anxiety toward implant surgery. Therefore, a question enquiring about patients' feelings towards implant surgery was added. | Other | Control group (CIS), Test group (s-CAIS) |
| Pain questionnairePatients were asked to describe the worst pain feeling using a standard 10 cm Visual Analog Scale (VAS) and the proportion of time spent in severe pain using a 5 category Likert scale. The number of analgesics taken per day was also asked. | Other | Control group (CIS), Test group (s-CAIS) |
| Oral Health-Related Quality of Life (OHRQoL) questionnaireThe OHRQoL comprises 14 questions covering problems the patient may in three main categories: oral function, daily activity, and post-operative symptoms (Chaushu, Becker, Zeltser, Vasker, \& Chaushu, 2004). Patients answered using a 5-category Likert scale. | Other | Control group (CIS), Test group (s-CAIS) |
Primary outcome
Change of post-operative pain for 7 days: Visual Analog Scale
Time frame: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.
Patients were asked to describe the worst post-operative pain feeling using a standard 10 cm Visual Analog Scale.
Change of the proportion of time spent in severe pain for 7 days: 5-category Likert scale
Time frame: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.
Patients were asked to describe the proportion of time spent in severe pain using 5-category Likert scale (None, Low, Moderate, High, Very high).
Change of the analgesics taken per day for 7 days: the number of tablets per day
Time frame: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.
Patients were asked to describe the number of analgesics taken per day.
Change of Oral Health-Related Quality of Life (OHRQoL) for 7 days: 5-category Likert scale
Time frame: Patients were instructed to answer the OHRQoL every day for 7 days starting from the day of surgery 1 hour before bedtime.
The OHRQoL questionnaire comprises 14 questions covering problems the patient may in three main categories: oral function, daily activity, and post-operative symptoms derived from Chaushu's study (Chaushu, Becker, Zeltser, Vasker, \& Chaushu, 2004). Patients answered this questionnaire using a 5-category Likert scale (Not at all, Very little, A little, Quite a lot, Very much).
1 secondary outcome
The Modified Dental Anxiety Score (MDAS)
Time frame: 1 day (Patients completed the modified MDAS once, while waiting for the surgery in the waiting room.)
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 6 Jul 2021.
- Background: PubMed 20497439Arisan V, Karabuda CZ, Ozdemir T. Implant surgery using bone- and mucosa-supported stereolithographic guides in totally edentulous jaws: surgical and post-operative outcomes of computer-aided vs. standard techniques. Clin Oral Implants Res. 2010 Sep;21(9):980-8. doi: 10.1111/j.1600-0501.2010.01957.x. Epub 2010 May 24.
- Background: PubMed 29510331Bielemann AM, Marcello-Machado RM, Del Bel Cury AA, Faot F. Systematic review of wound healing biomarkers in peri-implant crevicular fluid during osseointegration. Arch Oral Biol. 2018 May;89:107-128. doi: 10.1016/j.archoralbio.2018.02.013. Epub 2018 Feb 22.
- Background: PubMed 24158332Buser D, Chappuis V, Kuchler U, Bornstein MM, Wittneben JG, Buser R, Cavusoglu Y, Belser UC. Long-term stability of early implant placement with contour augmentation. J Dent Res. 2013 Dec;92(12 Suppl):176S-82S. doi: 10.1177/0022034513504949. Epub 2013 Oct 24.
- Background: PubMed 15635945Buser 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.
- Background: PubMed 24168680Calvert M, Brundage M, Jacobsen PB, Schunemann HJ, Efficace F. The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice. Health Qual Life Outcomes. 2013 Oct 29;11:184. doi: 10.1186/1477-7525-11-184.
- Background: PubMed 20465835Coolidge T, Hillstead MB, Farjo N, Weinstein P, Coldwell SE. Additional psychometric data for the Spanish Modified Dental Anxiety Scale, and psychometric data for a Spanish version of the Revised Dental Beliefs Survey. BMC Oral Health. 2010 May 13;10:12. doi: 10.1186/1472-6831-10-12.
- Background: PubMed 28000275D'haese J, Ackhurst J, Wismeijer D, De Bruyn H, Tahmaseb A. Current state of the art of computer-guided implant surgery. Periodontol 2000. 2017 Feb;73(1):121-133. doi: 10.1111/prd.12175.
- Background: PubMed 26385620De Bruyn H, Raes S, Matthys C, Cosyn J. The current use of patient-centered/reported outcomes in implant dentistry: a systematic review. Clin Oral Implants Res. 2015 Sep;26 Suppl 11:45-56. doi: 10.1111/clr.12634.
- Background: PubMed 30328187Feine J, Abou-Ayash S, Al Mardini M, de Santana RB, Bjelke-Holtermann T, Bornstein MM, Braegger U, Cao O, Cordaro L, Eycken D, Fillion M, Gebran G, Huynh-Ba G, Joda T, Levine R, Mattheos N, Oates TW, Abd-Ul-Salam H, Santosa R, Shahdad S, Storelli S, Sykaras N, Trevino Santos A, Stephanie Webersberger U, Williams MAH, Wilson TG Jr, Wismeijer D, Wittneben JG, Yao CJ, Zubiria JPV. Group 3 ITI Consensus Report: Patient-reported outcome measures associated with implant dentistry. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:270-275. doi: 10.1111/clr.13299.
- Background: PubMed 16634502Fortin T, Bosson JL, Isidori M, Blanchet E. Effect of flapless surgery on pain experienced in implant placement using an image-guided system. Int J Oral Maxillofac Implants. 2006 Mar-Apr;21(2):298-304.
- Background: PubMed 28251175Giri J, Pokharel PR, Gyawali R, Bhattarai B. Translation and Validation of Modified Dental Anxiety Scale: The Nepali Version. Int Sch Res Notices. 2017 Jan 29;2017:5495643. doi: 10.1155/2017/5495643. eCollection 2017.
- Background: PubMed 20952156Humphris G, King K. The prevalence of dental anxiety across previous distressing experiences. J Anxiety Disord. 2011 Mar;25(2):232-6. doi: 10.1016/j.janxdis.2010.09.007. Epub 2010 Sep 19.
- Individual participant dataSharing planned: No
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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.
Chatchai Kunavisarut, DDS study chair
Department of Advanced General Dentistry, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Dental Anxiety Score (MDAS) questionnaire, Pain questionnaire and Oral Health-Related Quality of Life (OHRQoL) questionnaire in people with Dental Implantation and Postoperative Pain, run by Mahidol University at 1 site in Thailand.
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 6 inclusion and 8 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 6 Jul 2021. 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 Thailand. 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?
Change of post-operative pain for 7 days: Visual Analog Scale (time frame: Patients were instructed to answer every day for 7 days starting from the day of surgery 1 hour before bedtime.). The study lists 4 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 NCT04950491, which also lists 27 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 6 Jul 2021.