Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Umeå University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this trial is to evaluate and compare stability after orthodontic treatment with an Essix retainer and a bonded cuspid-to-cuspid retainer (CTC), respectively in the mandibular arch and longitudinally follow these patients over time up to 5 years. The patients' perceptions of the two methods are also evaluated with questionnaires during the follow-up period.
A further aim of this study is to analyze the relationship between diagnosis, treatment outcome, treatment time, age at start of treatment and stability with an Essix retainer in the maxilla.
The null hypotheses are:
The study is conducted at the Orthodontic Clinic, Gävle, Sweden and consists of 104 patients. All patients are treated with fixed appliances in the upper and lower jaw (standard .022 straight wire), both with and without extractions. The patients are randomized into two groups with 52 patients in each group (Group A: cuspid-to-cuspid retainer, Group B: Essix retainer).
Dental cast are obtained at the debond appointment (T1) and at the follow-up controls after six months (T2), 18 months (T3) and 60 months (T4) for both groups.
At the visit two weeks in retention and at the follow-up visits after 6, 18 and 60 months the patients assess questionnaires in order to evaluate their experience of retention with the retention device.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: CTC retainer + Essix retainer | Experimental | The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits. |
|
| Group B: Essix retainer + Essix retainer | Active Comparator | The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTC retainer | Device | The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Tooth Position | Analyses of changes in tooth position on dental casts Little's Irregularity Index (in mm) 0=no crowding/irregularity, higher scores= more crowding/irregularity (worse outcome) | Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1) |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' Perception | Analyses of patients' perception by validated self-report questionnaires to evaluate experiences of the retention techniques VAS (visual analog scale, 0-100) 0= low satisfaction 100= high satisfaction | T4 (5 years follow up) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anke Krämer, DDS | Folktandvården Gävleborg AB, Specialisttandvården ortdonti | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18004927 | Background | Atack N, Harradine N, Sandy JR, Ireland AJ. Which way forward? Fixed or removable lower retainers. Angle Orthod. 2007 Nov;77(6):954-9. doi: 10.2319/103106-449.1. | |
| 10534980 | Background | Bennett ME, Tulloch JF. Understanding orthodontic treatment satisfaction from the patients' perspective: a qualitative approach. Clin Orthod Res. 1999 May;2(2):53-61. doi: 10.1111/ocr.1999.2.2.53. |
Not provided
Not provided
The participant data will be shared on reasonable request.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group A: CTC Retainer + Essix Retainer | The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits. CTC retainer: The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding. Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances. Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months. Questionnaire: A questionnaire is completed at the follow-up visits. |
| FG001 | Group B: Essix Retainer + Essix Retainer | The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits. Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances. Essix retainer mandible: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances. Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months. Questionnaire: A questionnaire is completed at the follow-up visits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
adolescent patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group A: CTC Retainer + Essix Retainer | The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits. CTC retainer: The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding. Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances. Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months. Questionnaire: A questionnaire is completed at the follow-up visits. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Tooth Position | Analyses of changes in tooth position on dental casts Little's Irregularity Index (in mm) 0=no crowding/irregularity, higher scores= more crowding/irregularity (worse outcome) | Dental casts were analysed. As data were not normal distributed, median values are reported. | Posted | Median | Inter-Quartile Range | millimeters | Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1) |
|
Observation time: 5 years after debonding (T1-T4)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: CTC Retainer + Essix Retainer | The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits. CTC retainer: The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding. Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances. Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months. Questionnaire: A questionnaire is completed at the follow-up visits. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anke Krämer | Folktandvården Gävleborg AB | +4625155680 | anke.kramer@regiongavleborg.se |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2009 | Apr 13, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000077744 | Orthodontic Appliances, Fixed |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D009967 | Orthodontic Appliances |
| D009970 | Orthodontics |
| D003813 | Dentistry |
| D003625 | Data Collection |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Essix retainer maxilla | Device | The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances. |
|
|
| Essix retainer mandible | Device | The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances. |
|
|
| Alginate impression | Procedure | Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months. |
|
| Questionnaire | Other | A questionnaire is completed at the follow-up visits. |
|
| 17319767 | Background | Feldmann I, List T, John MT, Bondemark L. Reliability of a questionnaire assessing experiences of adolescents in orthodontic treatment. Angle Orthod. 2007 Mar;77(2):311-7. doi: 10.2319/0003-3219(2007)077[0311:ROAQAE]2.0.CO;2. |
| 21300723 | Background | Feldmann I, List T, Bondemark L. Orthodontic anchoring techniques and its influence on pain, discomfort, and jaw function--a randomized controlled trial. Eur J Orthod. 2012 Feb;34(1):102-8. doi: 10.1093/ejo/cjq171. Epub 2011 Feb 7. |
| 17702797 | Background | Hichens L, Rowland H, Williams A, Hollinghurst S, Ewings P, Clark S, Ireland A, Sandy J. Cost-effectiveness and patient satisfaction: Hawley and vacuum-formed retainers. Eur J Orthod. 2007 Aug;29(4):372-8. doi: 10.1093/ejo/cjm039. |
| 21508267 | Background | Jaderberg S, Feldmann I, Engstrom C. Removable thermoplastic appliances as orthodontic retainers--a prospective study of different wear regimens. Eur J Orthod. 2012 Aug;34(4):475-9. doi: 10.1093/ejo/cjr040. Epub 2011 Apr 20. |
| 9709631 | Background | Lindauer SJ, Shoff RC. Comparison of Essix and Hawley retainers. J Clin Orthod. 1998 Feb;32(2):95-7. No abstract available. |
| 26824885 | Background | Littlewood SJ, Millett DT, Doubleday B, Bearn DR, Worthington HV. Retention procedures for stabilising tooth position after treatment with orthodontic braces. Cochrane Database Syst Rev. 2016 Jan 29;2016(1):CD002283. doi: 10.1002/14651858.CD002283.pub4. |
| 21696115 | Background | Kumar AG, Bansal A. Effectiveness and acceptability of Essix and Begg retainers: a prospective study. Aust Orthod J. 2011 May;27(1):52-6. |
| 5233926 | Background | Reitan K. Clinical and histologic observations on tooth movement during and after orthodontic treatment. Am J Orthod. 1967 Oct;53(10):721-45. doi: 10.1016/0002-9416(67)90118-2. No abstract available. |
| 18675196 | Background | Renkema AM, Al-Assad S, Bronkhorst E, Weindel S, Katsaros C, Lisson JA. Effectiveness of lingual retainers bonded to the canines in preventing mandibular incisor relapse. Am J Orthod Dentofacial Orthop. 2008 Aug;134(2):179e1-8. doi: 10.1016/j.ajodo.2008.06.003. |
| 18068589 | Background | Rowland H, Hichens L, Williams A, Hills D, Killingback N, Ewings P, Clark S, Ireland AJ, Sandy JR. The effectiveness of Hawley and vacuum-formed retainers: a single-center randomized controlled trial. Am J Orthod Dentofacial Orthop. 2007 Dec;132(6):730-7. doi: 10.1016/j.ajodo.2006.06.019. |
| 8478438 | Background | Sheridan JJ, LeDoux W, McMinn R. Essix retainers: fabrication and supervision for permanent retention. J Clin Orthod. 1993 Jan;27(1):37-45. No abstract available. |
| 19828592 | Background | Thickett E, Power S. A randomized clinical trial of thermoplastic retainer wear. Eur J Orthod. 2010 Feb;32(1):1-5. doi: 10.1093/ejo/cjp061. Epub 2009 Oct 14. |
| 24014170 | Background | Yu Y, Sun J, Lai W, Wu T, Koshy S, Shi Z. Interventions for managing relapse of the lower front teeth after orthodontic treatment. Cochrane Database Syst Rev. 2013 Sep 6;2013(9):CD008734. doi: 10.1002/14651858.CD008734.pub2. |
| 36526846 | Derived | Steegmans PAJ, Cavagnetto D, Reynders RAM. Which orthodontic retention protocol should I implement? A critical assessment of a randomised controlled trial. Evid Based Dent. 2022 Dec;23(4):162-165. doi: 10.1038/s41432-022-0845-7. Epub 2022 Dec 16. |
| 35968668 | Derived | Kramer A, Sjostrom M, Apelthun C, Hallman M, Feldmann I. Post-treatment stability after 5 years of retention with vacuum-formed and bonded retainers-a randomized controlled trial. Eur J Orthod. 2023 Feb 10;45(1):68-78. doi: 10.1093/ejo/cjac043. |
| 32613244 | Derived | Kramer A, Sjostrom M, Hallman M, Feldmann I. Vacuum-formed retainers and bonded retainers for dental stabilization-a randomized controlled trial. Part II: patients' perceptions 6 and 18 months after orthodontic treatment. Eur J Orthod. 2021 Apr 3;43(2):136-143. doi: 10.1093/ejo/cjaa039. |
| 31665279 | Derived | Kramer A, Sjostrom M, Hallman M, Feldmann I. Vacuum-formed retainer versus bonded retainer for dental stabilization in the mandible-a randomized controlled trial. Part I: retentive capacity 6 and 18 months after orthodontic treatment. Eur J Orthod. 2020 Nov 3;42(5):551-558. doi: 10.1093/ejo/cjz072. |
| BG001 | Group B: Essix Retainer + Essix Retainer | The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits. Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances. Essix retainer mandible: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances. Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months. Questionnaire: A questionnaire is completed at the follow-up visits. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Group B: Essix Retainer + Essix Retainer | The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits. Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances. Essix retainer mandible: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances. Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months. Questionnaire: A questionnaire is completed at the follow-up visits. |
|
|
|
| Secondary | Patients' Perception | Analyses of patients' perception by validated self-report questionnaires to evaluate experiences of the retention techniques VAS (visual analog scale, 0-100) 0= low satisfaction 100= high satisfaction | Adolescent patients at debond (baseline), adults after 5 years | Posted | Median | Inter-Quartile Range | score on a scale | T4 (5 years follow up) |
|
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Group B: Essix Retainer + Essix Retainer | The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits. Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances. Essix retainer mandible: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances. Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months. Questionnaire: A questionnaire is completed at the follow-up visits. | 0 | 52 | 0 | 52 | 0 | 52 |
Not provided
Not provided
| D004812 |
| Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |