Effectiveness of Removable Prosthesis Retained by 4 Implant-supported Locator-Attachments
NCT ID: NCT02380404
Last Updated: 2022-05-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
30 participants
Study Classification
OBSERVATIONAL
Study Start Date
2014-04-02
Study Completion Date
2020-11-30
Brief Summary
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1\. Hypothesis/Specific aims
The aim of the present study proposal is to validate an implant treatment concept in the edentulous upper maxilla using four implants-supported locators abutments to retain removable prosthesis.
Specific aims:
* The primary objective of the study is to evaluate the implant and prosthodontics success rates of the proposed implant treatment approach after a follow-up period of 1, 3 and 5 years as well as the biological and prosthodontics complications.
* The secondary objective is to assess the evolution of patient centered outcomes with the suggested treatment in the maxilla. Oral health-related quality of life (OHRQoL) and patients' satisfaction relating to their prostheses will be considered.
* The third objective will be to compare the implant, prosthodontics and patient-centered outcomes according to the implant distribution; 4 anterior to maxillary sinus (ANT) versus 2 anterior implants and 2 implants in the maxillary tuberosity (POST).
Hypothesis:
* Implant survival rate using this treatment concept is similar to restoration with implant-supported fixed prosthesis, based on published data. No difference of implant survival rates is found between ANT and POST implant distribution.
* Prosthodontics survival rate using the following treatment concept is similar to the ones found with a bar, based on published data. The ANT implant distribution causes fewer prosthodontics complications compared to the POST implant distribution.
* There is a significant improvement in OHRQoL and patient satisfaction compared to the baseline OHRQoL observed with a conventional removable denture. The levels of improvement OHRQoL and patient satisfaction are similar for ANT and POST implant distributions.
The aim of the present study proposal is to validate an implant treatment concept in the edentulous upper maxilla using four implants-supported locators abutments to retain removable prosthesis.
Specific aims:
* The primary objective of the study is to evaluate the implant and prosthodontics success rates of the proposed implant treatment approach after a follow-up period of 1, 3 and 5 years as well as the biological and prosthodontics complications.
* The secondary objective is to assess the evolution of patient centered outcomes with the suggested treatment in the maxilla. Oral health-related quality of life (OHRQoL) and patients' satisfaction relating to their prostheses will be considered.
* The third objective will be to compare the implant, prosthodontics and patient-centered outcomes according to the implant distribution; 4 anterior to maxillary sinus (ANT) versus 2 anterior implants and 2 implants in the maxillary tuberosity (POST).
Hypothesis:
* Implant survival rate using this treatment concept is similar to restoration with implant-supported fixed prosthesis, based on published data. No difference of implant survival rates is found between ANT and POST implant distribution.
* Prosthodontics survival rate using the following treatment concept is similar to the ones found with a bar, based on published data. The ANT implant distribution causes fewer prosthodontics complications compared to the POST implant distribution.
* There is a significant improvement in OHRQoL and patient satisfaction compared to the baseline OHRQoL observed with a conventional removable denture. The levels of improvement OHRQoL and patient satisfaction are similar for ANT and POST implant distributions.
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Detailed Description
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1.1 Background and significance
The effectiveness of mandibular overdentures retained by 2 dental implants and its impact on Oral Health-Related Quality of Life (OHRQoL) and patient satisfaction has been extensively documented over the last decades(1-6). According to recent systematic reviews, the implant survival rate of this oral rehabilitation concept reaches more than 95% (7-10). The scientific validation of the efficacy of such a rehabilitation concept has influenced the social security system of several countries like Belgium. Therefore, this treatment approach is nowadays considered as an evidence-based and cost-effective treatment option improving the function and quality of life of mandibular edentulous patients. Unfortunately, cost-effective treatment concept to restore the edentulous maxilla not has been widely documented (11). Many studies display high success rates of fixed implant-supported rehabilitations of the edentulous maxilla (12) but these treatment options remain costly and are therefore reserved to a limited social category of patients.
This work is important because there is a need to provide affordable and efficient implant treatment approaches to restore function and improve satisfaction and OHRQoL of patients with edentulous maxillae.
1.2 Preliminary studies in connection with new projects/continuing projects
Even though some authors have described implant survival rates of implant-retained overdentures in the upper maxilla (8, 13-16), most of the treatment approaches involves bars. The placement of 4 implants and individual attachments is a more cost-effective treatment modality that is poorly documented in the literature in terms of implants and prosthodontics outcomes but also on aspects assessing implant distribution, attachment types and improvement of patient centered outcomes. Therefore, further studies are needed to validate the placement of 4 implants and individual attachment as a reliable treatment modality.
1.3 Research design and methods
The study is designed as a single center prospective cohort study. The study protocol will be submitted to the Ethics Committee of the University Hospital of the University of Liège, Belgium.
A total of 30 patients with edentulous maxillae and at least one short span dentition (fixed) in the lower jaw will be included in the study.
The inclusion and exclusion criteria are listed below:
Inclusion criteria
* Physical status according to the American Society of Anesthesiologists (ASA) = 1, 2
* Wearing a complete upper denture that is adequate and in good conditions
* Signed informed consent form describing the purpose and process of the study
Exclusion criteria
* Uncontrolled periodontitis/peri-implantitis (lower jaw)
* Lack of bone for the placement of 4 implants of 3.3 diameter and 8 mm with bone regeneration.
* Tobacco use \> 10cigarettes/day
Pre-treatment examination Clinical evaluation of the upper removable denture and the lower dentition will be done. Oral hygiene instructions will be given.
The patient fulfilling the inclusion criteria will be asked to complete 3 questionnaires for patient satisfaction and OHRQoL and socio-demographic conditions before explaining them the possibilities to be enrolled in a study in order to minimize the risk of bias.
The McGill Denture Satisfaction Instrument (17) will be used to evaluate patients' satisfaction relating to their prostheses. This questionnaire is a treatment-specific patient-based outcome assessing satisfaction relating to 6 aspects of the mandibular prosthesis: general satisfaction, comfort, stability, aesthetics, chewing ability (ease of chewing), chewing efficiency (ability to crush food in small particles), ease of cleaning, ability to speak and oral condition (condition of their mouth, which can refer to oral health status and was measured by "In general, are you satisfied with your oral condition?". The subjects will answer on 100 mm visual analogue scales (VAS) anchored by the words "not at all satisfied" and "extremely satisfied".
The Oral Health Impact Profile (OHIP-20) questionnaire will be used to assess oral health-related quality of life. This 20-item questionnaire measures self-reported impairment in edentulous populations within seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. The items will be rated on six-point Likert scales ("never" = 1, "rarely" = 2, "occasionally" = 3, "often" = 4, "very often" = 5 or "all of the time" = 6). OHIP-20s total range is therefore 20-120 points, lower scores indicating better oral health-related quality of life (4, 18, 19).
Data on gender, age, level of education, annual household revenue, marital status and lifestyle (living alone or with others) will be obtained from a standard socio-demographic questionnaire.
Cone beam CT s assessment After the informed consent is signed, a CT scan will be done and evaluated by 2 independent surgeons to potentially exclude some patients because of lack of bone availability. In case of disagreement, the case will be discussed.
Surgical procedures Once all patients have been enrolled in the study, the surgeries will be scheduled within the same week. Antibiotics will be prescribed 1 day before surgery and continued for 5 days. Three calibrated and confirmed surgeons will place 4 Narrow Neck (NN) or Regular Neck (RN) Roxolid tissue level implants (Institut Straumann, Basel Switzerland) according to the surgical protocol recommended by the manufacturer. The implant positions have to be determined previously at the time of CT scan evaluation by an agreement between the 2 operators and according to the bone availability. Two implants have to be placed in the lateral or canine region and 2 implants as distal as possible. The implants have to be placed with as parallels as possible. A maximum divergence of 10 will be tolerated. The flap design will be determined according to the available bone quantity and in order to emphasize an adequate quantity of keratinized tissue around the implants. A Cone Beam Computed Tomography (CBCT) scan will be done directly after surgery. Sutures will be performed with silk sutures and removed after 1 week. The removable (conventional) prostheses will be adapted to avoid any contact with the implants. Patients will be followed up at 4 and 8 weeks post-surgery, respectively. At 8 weeks, a panoramic x-ray will be done. If osseointegration is successful, the removable prostheses will be connected to the implants.
Prosthodontics procedures At 8 weeks, prosthesis will be connected to the implant with Locator . The type of Locator attachments will be chosen according to the implant angulation and soft tissue thickness. They will be torqued at 35 N/cm on the osseointegrated implants. Afterwards, the female connection will be fixed into the removable prosthesis with acrylic resin. The effectiveness of retention will be checked and the patient will be taught to put the denture in and out by himself. The occlusion will be controlled and adjusted after these manipulations if necessary.
Follow-up visits Patient will be followed at 1 week after Locator connections and then at 3, 6 and 12 months, respectively. Thereafter, patients were recalled annually. In case of any complications, the patient will be asked to directly contact one of the dentists responsible for the study.
Data collection Data will be collected into a remote and secured database. Automatic data check procedures will be implemented at data entry to warrant quality of the information stored. Access to the database will be limited to the study investigators and data will be kept confidential.
Statistical analyses Results will be summarized as mean and standard deviation (SD) for quantitative variables and as frequency tables for categorical findings at each time point. Longitudinal data will be displayed graphically and analyzed by the general linear mixed model which accounts for repeated values within patients. Success rates will be estimated and associated with 95% confidence intervals (95%CI). The significance level will be set at 5% (P\<0.05). Data will be analyzed with Statistical Analyses Software (SAS and S-PLUS softwares).
The effectiveness of mandibular overdentures retained by 2 dental implants and its impact on Oral Health-Related Quality of Life (OHRQoL) and patient satisfaction has been extensively documented over the last decades(1-6). According to recent systematic reviews, the implant survival rate of this oral rehabilitation concept reaches more than 95% (7-10). The scientific validation of the efficacy of such a rehabilitation concept has influenced the social security system of several countries like Belgium. Therefore, this treatment approach is nowadays considered as an evidence-based and cost-effective treatment option improving the function and quality of life of mandibular edentulous patients. Unfortunately, cost-effective treatment concept to restore the edentulous maxilla not has been widely documented (11). Many studies display high success rates of fixed implant-supported rehabilitations of the edentulous maxilla (12) but these treatment options remain costly and are therefore reserved to a limited social category of patients.
This work is important because there is a need to provide affordable and efficient implant treatment approaches to restore function and improve satisfaction and OHRQoL of patients with edentulous maxillae.
1.2 Preliminary studies in connection with new projects/continuing projects
Even though some authors have described implant survival rates of implant-retained overdentures in the upper maxilla (8, 13-16), most of the treatment approaches involves bars. The placement of 4 implants and individual attachments is a more cost-effective treatment modality that is poorly documented in the literature in terms of implants and prosthodontics outcomes but also on aspects assessing implant distribution, attachment types and improvement of patient centered outcomes. Therefore, further studies are needed to validate the placement of 4 implants and individual attachment as a reliable treatment modality.
1.3 Research design and methods
The study is designed as a single center prospective cohort study. The study protocol will be submitted to the Ethics Committee of the University Hospital of the University of Liège, Belgium.
A total of 30 patients with edentulous maxillae and at least one short span dentition (fixed) in the lower jaw will be included in the study.
The inclusion and exclusion criteria are listed below:
Inclusion criteria
* Physical status according to the American Society of Anesthesiologists (ASA) = 1, 2
* Wearing a complete upper denture that is adequate and in good conditions
* Signed informed consent form describing the purpose and process of the study
Exclusion criteria
* Uncontrolled periodontitis/peri-implantitis (lower jaw)
* Lack of bone for the placement of 4 implants of 3.3 diameter and 8 mm with bone regeneration.
* Tobacco use \> 10cigarettes/day
Pre-treatment examination Clinical evaluation of the upper removable denture and the lower dentition will be done. Oral hygiene instructions will be given.
The patient fulfilling the inclusion criteria will be asked to complete 3 questionnaires for patient satisfaction and OHRQoL and socio-demographic conditions before explaining them the possibilities to be enrolled in a study in order to minimize the risk of bias.
The McGill Denture Satisfaction Instrument (17) will be used to evaluate patients' satisfaction relating to their prostheses. This questionnaire is a treatment-specific patient-based outcome assessing satisfaction relating to 6 aspects of the mandibular prosthesis: general satisfaction, comfort, stability, aesthetics, chewing ability (ease of chewing), chewing efficiency (ability to crush food in small particles), ease of cleaning, ability to speak and oral condition (condition of their mouth, which can refer to oral health status and was measured by "In general, are you satisfied with your oral condition?". The subjects will answer on 100 mm visual analogue scales (VAS) anchored by the words "not at all satisfied" and "extremely satisfied".
The Oral Health Impact Profile (OHIP-20) questionnaire will be used to assess oral health-related quality of life. This 20-item questionnaire measures self-reported impairment in edentulous populations within seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. The items will be rated on six-point Likert scales ("never" = 1, "rarely" = 2, "occasionally" = 3, "often" = 4, "very often" = 5 or "all of the time" = 6). OHIP-20s total range is therefore 20-120 points, lower scores indicating better oral health-related quality of life (4, 18, 19).
Data on gender, age, level of education, annual household revenue, marital status and lifestyle (living alone or with others) will be obtained from a standard socio-demographic questionnaire.
Cone beam CT s assessment After the informed consent is signed, a CT scan will be done and evaluated by 2 independent surgeons to potentially exclude some patients because of lack of bone availability. In case of disagreement, the case will be discussed.
Surgical procedures Once all patients have been enrolled in the study, the surgeries will be scheduled within the same week. Antibiotics will be prescribed 1 day before surgery and continued for 5 days. Three calibrated and confirmed surgeons will place 4 Narrow Neck (NN) or Regular Neck (RN) Roxolid tissue level implants (Institut Straumann, Basel Switzerland) according to the surgical protocol recommended by the manufacturer. The implant positions have to be determined previously at the time of CT scan evaluation by an agreement between the 2 operators and according to the bone availability. Two implants have to be placed in the lateral or canine region and 2 implants as distal as possible. The implants have to be placed with as parallels as possible. A maximum divergence of 10 will be tolerated. The flap design will be determined according to the available bone quantity and in order to emphasize an adequate quantity of keratinized tissue around the implants. A Cone Beam Computed Tomography (CBCT) scan will be done directly after surgery. Sutures will be performed with silk sutures and removed after 1 week. The removable (conventional) prostheses will be adapted to avoid any contact with the implants. Patients will be followed up at 4 and 8 weeks post-surgery, respectively. At 8 weeks, a panoramic x-ray will be done. If osseointegration is successful, the removable prostheses will be connected to the implants.
Prosthodontics procedures At 8 weeks, prosthesis will be connected to the implant with Locator . The type of Locator attachments will be chosen according to the implant angulation and soft tissue thickness. They will be torqued at 35 N/cm on the osseointegrated implants. Afterwards, the female connection will be fixed into the removable prosthesis with acrylic resin. The effectiveness of retention will be checked and the patient will be taught to put the denture in and out by himself. The occlusion will be controlled and adjusted after these manipulations if necessary.
Follow-up visits Patient will be followed at 1 week after Locator connections and then at 3, 6 and 12 months, respectively. Thereafter, patients were recalled annually. In case of any complications, the patient will be asked to directly contact one of the dentists responsible for the study.
Data collection Data will be collected into a remote and secured database. Automatic data check procedures will be implemented at data entry to warrant quality of the information stored. Access to the database will be limited to the study investigators and data will be kept confidential.
Statistical analyses Results will be summarized as mean and standard deviation (SD) for quantitative variables and as frequency tables for categorical findings at each time point. Longitudinal data will be displayed graphically and analyzed by the general linear mixed model which accounts for repeated values within patients. Success rates will be estimated and associated with 95% confidence intervals (95%CI). The significance level will be set at 5% (P\<0.05). Data will be analyzed with Statistical Analyses Software (SAS and S-PLUS softwares).
Conditions
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Edentulous Alveolar Ridge
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Edentulous maxilla
Ibuprofen (600 mg - Film-coated Tablets) 3x/day before the surgery. Duration : 5 days Amoxicilline Teva (500 mg - dispersible tablets) 3x/day before the surgery. Duration : 16 days
Implants-supported locators placement
Intervention Type
PROCEDURE
Antibiotics will be prescribed 1 day before surgery and continued for 5 days. Three calibrated surgeons will place 4 NN or RN Roxolid tissue level implants. Two implants have to be placed in the ANT region (lateral or canine) and 2 implants in the POST region (as distal as possible). Angulated implant and placement of implant in the tuberosity region can be considered.
Interventions
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Implants-supported locators placement
Antibiotics will be prescribed 1 day before surgery and continued for 5 days. Three calibrated surgeons will place 4 NN or RN Roxolid tissue level implants. Two implants have to be placed in the ANT region (lateral or canine) and 2 implants in the POST region (as distal as possible). Angulated implant and placement of implant in the tuberosity region can be considered.
Intervention Type
PROCEDURE
Other Intervention Names
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Locators abutments
NN or RN Roxolid tissue level implants
Eligibility Criteria
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Inclusion Criteria
* Physical status according to ASA = 1, 2
* Wearing a complete upper denture that is adequate and in good conditions
* Signed informed consent form describing the purpose and process of the study
* Wearing a complete upper denture that is adequate and in good conditions
* Signed informed consent form describing the purpose and process of the study
Exclusion Criteria
* Uncontrolled periodontitis/peri-implantitis (lower jaw)
* Lack of bone for the placement of 4 implants of 3.3 diameter and 8 mm with bone regeneration.
* Tobacco use \> 10cigarettes/day
* Lack of bone for the placement of 4 implants of 3.3 diameter and 8 mm with bone regeneration.
* Tobacco use \> 10cigarettes/day
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Université de Liège
OTHER
Sponsor Role
collaborator
ITI International Team for Implantology, Switzerland
OTHER
Sponsor Role
collaborator
Institut Straumann AG
INDUSTRY
Sponsor Role
collaborator
University of Liege
OTHER
Sponsor Role
lead
Responsible Party
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Dr. France LAMBERT
Head of Clinic
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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France Lambert
Role: PRINCIPAL_INVESTIGATOR
CHU of Liège
Locations
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Hospital University of Liège (CHU-Ulg)
Liège, , Belgium
Site Status
University Hospital of Liege
Liège, , Belgium
Site Status
Countries
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Belgium
References
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Assuncao WG, Barao VA, Delben JA, Gomes EA, Tabata LF. A comparison of patient satisfaction between treatment with conventional complete dentures and overdentures in the elderly: a literature review. Gerodontology. 2010 Jun;27(2):154-62. doi: 10.1111/j.1741-2358.2009.00299.x. Epub 2009 May 6.
Reference Type
BACKGROUND
Awad MA, Locker D, Korner-Bitensky N, Feine JS. Measuring the effect of intra-oral implant rehabilitation on health-related quality of life in a randomized controlled clinical trial. J Dent Res. 2000 Sep;79(9):1659-63. doi: 10.1177/00220345000790090401.
Reference Type
BACKGROUND
Awad MA, Lund JP, Dufresne E, Feine JS. Comparing the efficacy of mandibular implant-retained overdentures and conventional dentures among middle-aged edentulous patients: satisfaction and functional assessment. Int J Prosthodont. 2003 Mar-Apr;16(2):117-22.
Reference Type
BACKGROUND
Awad MA, Rashid F, Feine JS; Overdenture Effectiveness Study Team Consortium. The effect of mandibular 2-implant overdentures on oral health-related quality of life: an international multicentre study. Clin Oral Implants Res. 2014 Jan;25(1):46-51. doi: 10.1111/clr.12205. Epub 2013 Jun 4.
Reference Type
BACKGROUND
Heydecke G, Penrod JR, Takanashi Y, Lund JP, Feine JS, Thomason JM. Cost-effectiveness of mandibular two-implant overdentures and conventional dentures in the edentulous elderly. J Dent Res. 2005 Sep;84(9):794-9. doi: 10.1177/154405910508400903.
Reference Type
BACKGROUND
Wismeijer D, Tawse-Smith A, Payne AG. Multicentre prospective evaluation of implant-assisted mandibular bilateral distal extension removable partial dentures: patient satisfaction. Clin Oral Implants Res. 2013 Jan;24(1):20-7. doi: 10.1111/j.1600-0501.2011.02367.x. Epub 2011 Nov 24.
Reference Type
BACKGROUND
Batenburg RH, Meijer HJ, Raghoebar GM, Vissink A. Treatment concept for mandibular overdentures supported by endosseous implants: a literature review. Int J Oral Maxillofac Implants. 1998 Jul-Aug;13(4):539-45.
Reference Type
BACKGROUND
Slot W, Raghoebar GM, Vissink A, Huddleston Slater JJ, Meijer HJ. A systematic review of implant-supported maxillary overdentures after a mean observation period of at least 1 year. J Clin Periodontol. 2010 Jan;37(1):98-110. doi: 10.1111/j.1600-051X.2009.01493.x. Epub 2009 Dec 7.
Reference Type
BACKGROUND
de Lange J, van Gool AV, Stoker G, Wismeijer D, van Waas R. An eight-year follow-up to a randomized clinical trial of aftercare and cost-analysis with three types of mandibular implant-retained overdentures. J Dent Res. 2007 Oct;86(10):920; author reply 920-1. doi: 10.1177/154405910708601003. No abstract available.
Reference Type
BACKGROUND
Stoker G, van Waas R, Wismeijer D. Long-term outcomes of three types of implant-supported mandibular overdentures in smokers. Clin Oral Implants Res. 2012 Aug;23(8):925-9. doi: 10.1111/j.1600-0501.2011.02237.x. Epub 2011 Jul 4.
Reference Type
BACKGROUND
Zembic A, Wismeijer D. Patient-reported outcomes of maxillary implant-supported overdentures compared with conventional dentures. Clin Oral Implants Res. 2014 Apr;25(4):441-50. doi: 10.1111/clr.12169. Epub 2013 Apr 15.
Reference Type
BACKGROUND
Lambert FE, Weber HP, Susarla SM, Belser UC, Gallucci GO. Descriptive analysis of implant and prosthodontic survival rates with fixed implant-supported rehabilitations in the edentulous maxilla. J Periodontol. 2009 Aug;80(8):1220-30. doi: 10.1902/jop.2009.090109.
Reference Type
BACKGROUND
Laurito D, Lamazza L, Spink MJ, De Biase A. Tissue-supported dental implant prosthesis (overdenture): the search for the ideal protocol. A literature review. Ann Stomatol (Roma). 2012 Jan;3(1):2-10. Epub 2012 May 3.
Reference Type
BACKGROUND
Slot W, Raghoebar GM, Vissink A, Meijer HJ. Maxillary overdentures supported by anteriorly or posteriorly placed implants opposed by a natural dentition in the mandible: a 1-year prospective case series study. Clin Implant Dent Relat Res. 2014 Feb;16(1):51-61. doi: 10.1111/j.1708-8208.2012.00459.x. Epub 2012 May 11.
Reference Type
BACKGROUND
Slot W, Raghoebar GM, Vissink A, Meijer HJ. A comparison between 4 and 6 implants in the maxillary posterior region to support an overdenture; 1-year results from a randomized controlled trial. Clin Oral Implants Res. 2014 May;25(5):560-6. doi: 10.1111/clr.12118. Epub 2013 Feb 13.
Reference Type
BACKGROUND
Michaud PL, de Grandmont P, Feine JS, Emami E. Measuring patient-based outcomes: is treatment satisfaction associated with oral health-related quality of life? J Dent. 2012 Aug;40(8):624-31. doi: 10.1016/j.jdent.2012.04.007. Epub 2012 Apr 20.
Reference Type
BACKGROUND
Allen F, Locker D. A modified short version of the oral health impact profile for assessing health-related quality of life in edentulous adults. Int J Prosthodont. 2002 Sep-Oct;15(5):446-50.
Reference Type
BACKGROUND
Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
Reference Type
BACKGROUND
Other Identifiers
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958_2013
Identifier Type: -
Identifier Source: org_study_id
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