Patient-reported Outcome Measures Comparing Static Computer-aided Implant Surgery and Conventional Implant Surgery
NCT ID: NCT04950491
Last Updated: 2021-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2019-07-09
2021-03-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Accuracy of s-CAIS Compared With c-LIS
NCT05361226
PROMs Comparing Digital & Conventional Workflows
NCT04986761
Patient Satisfaction and OHRQoL In Removable Versus Fixed Implant Prostheses
NCT04694209
This Study Will Assess Whether the Treatment Provided by Dentist is Successful in Meeting the Expectations of Patient by Asking Questions Related to Aesthetics, Chewing Ability, Comfort and Phonetics Before and After Providing Treatment and the Patient Will Tell Through Visual Analog Scale
NCT07100678
Impact of Removable Versus Fixed Implant-supported Prostheses in Oral Health Quality of Life for Edentulous Patients
NCT05162963
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Test group (s-CAIS)
The test group workflow used a fully computer-guided implant surgical protocol.
Modified Dental Anxiety Score (MDAS) questionnaire
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 questionnaire
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) questionnaire
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.
Control group (CIS)
The control group workflow used a conventional implant surgical protocol.
Modified Dental Anxiety Score (MDAS) questionnaire
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 questionnaire
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) questionnaire
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Modified Dental Anxiety Score (MDAS) questionnaire
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 questionnaire
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) questionnaire
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
25 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ITI Foundation
INDUSTRY
Mahidol University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Akarin Santivitoonvong
Doctor of Dental Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chatchai Kunavisarut, DDS
Role: STUDY_CHAIR
Department of Advanced General Dentistry, Faculty of Dentistry
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Dentistry, Mahidol University
Ratchathewi, Bangkok, Thailand
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Bielemann 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.
Buser 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.
Buser 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.
Calvert 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.
Coolidge 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.
D'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.
De 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.
Feine 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.
Fortin 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.
Giri 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.
Humphris 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.
Humphris GM, Morrison T, Lindsay SJ. The Modified Dental Anxiety Scale: validation and United Kingdom norms. Community Dent Health. 1995 Sep;12(3):143-50.
Iqbal 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.
Joda 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.
McGrath C, Lam O, Lang N. An evidence-based review of patient-reported outcome measures in dental implant research among dentate subjects. J Clin Periodontol. 2012 Feb;39 Suppl 12:193-201. doi: 10.1111/j.1600-051X.2011.01841.x.
Nkenke E, Eitner S, Radespiel-Troger M, Vairaktaris E, Neukam FW, Fenner M. Patient-centred outcomes comparing transmucosal implant placement with an open approach in the maxilla: a prospective, non-randomized pilot study. Clin Oral Implants Res. 2007 Apr;18(2):197-203. doi: 10.1111/j.1600-0501.2006.01335.x.
Sancho-Puchades M, Alfaro FH, Naenni N, Jung R, Hammerle C, Schneider D. A Randomized Controlled Clinical Trial Comparing Conventional And Computer-Assisted Implant Planning and Placement in Partially Edentulous Patients. Part 2: Patient Related Outcome Measures. Int J Periodontics Restorative Dent. 2019 Jul/Aug;39(4):e99-e110. doi: 10.11607/prd.4145.
Sculean A, Gruber R, Bosshardt DD. Soft tissue wound healing around teeth and dental implants. J Clin Periodontol. 2014 Apr;41 Suppl 15:S6-22. doi: 10.1111/jcpe.12206.
Tarnow DP, Cho SC, Wallace SS. The effect of inter-implant distance on the height of inter-implant bone crest. J Periodontol. 2000 Apr;71(4):546-9. doi: 10.1902/jop.2000.71.4.546.
Vercruyssen M, Fortin T, Widmann G, Jacobs R, Quirynen M. Different techniques of static/dynamic guided implant surgery: modalities and indications. Periodontol 2000. 2014 Oct;66(1):214-27. doi: 10.1111/prd.12056.
Vercruyssen M, van de Wiele G, Teughels W, Naert I, Jacobs R, Quirynen M. Implant- and patient-centred outcomes of guided surgery, a 1-year follow-up: An RCT comparing guided surgery with conventional implant placement. J Clin Periodontol. 2014 Dec;41(12):1154-60. doi: 10.1111/jcpe.12305. Epub 2014 Oct 11.
von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med. 2007 Oct 16;147(8):573-7. doi: 10.7326/0003-4819-147-8-200710160-00010.
Wismeijer D, Joda T, Flugge T, Fokas G, Tahmaseb A, Bechelli D, Bohner L, Bornstein M, Burgoyne A, Caram S, Carmichael R, Chen CY, Coucke W, Derksen W, Donos N, El Kholy K, Evans C, Fehmer V, Fickl S, Fragola G, Gimenez Gonzales B, Gholami H, Hashim D, Hui Y, Kokat A, Vazouras K, Kuhl S, Lanis A, Leesungbok R, van der Meer J, Liu Z, Sato T, De Souza A, Scarfe WC, Tosta M, van Zyl P, Vach K, Vaughn V, Vucetic M, Wang P, Wen B, Wu V. Group 5 ITI Consensus Report: Digital technologies. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:436-442. doi: 10.1111/clr.13309.
Yuan S, Freeman R, Lahti S, Lloyd-Williams F, Humphris G. Some psychometric properties of the Chinese version of the Modified Dental Anxiety Scale with cross validation. Health Qual Life Outcomes. 2008 Mar 25;6:22. doi: 10.1186/1477-7525-6-22.
Chaushu S, Becker A, Zeltser R, Vasker N, Chaushu G. Patients' perceptions of recovery after surgical exposure of impacted maxillary teeth treated with an open-eruption surgical-orthodontic technique. Eur J Orthod. 2004 Dec;26(6):591-6. doi: 10.1093/ejo/26.6.591.
Humphris GM, Dyer TA, Robinson PG. The modified dental anxiety scale: UK general public population norms in 2008 with further psychometrics and effects of age. BMC Oral Health. 2009 Aug 26;9:20. doi: 10.1186/1472-6831-9-20.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DT 071/2019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.