Cepa 2017.
Methods | Trial design: 3‐year follow‐up, randomised parallel group trial Parallel group randomised clinical trial in which the individuals were randomly assigned to the 2 trial groups consisting of ball and telescopic attachments. Randomisation was carried out by a statistician not involved in the trial using sealed envelopes. The envelope containing information on the abutments to be used was opened by a dental nurse |
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Participants | Inclusion criteria: participants recruited for the trial were dissatisfied with their conventional mandibular overdenture Exclusion criteria: general contraindications for oral surgical procedures such as infectious or metabolic diseases, cardiovascular disease and pregnancy; local contraindications (e.g. tumours, ulcers); alcohol abuse or smoking; psychological disease; non‐compliance and intolerance of pre‐ or post‐operative medication in the presence of chronic disease Age at baseline (years): mean 65.2 Gender (M/F): not specified Number of mandibular overdentures randomised: 25 (mandibular 2‐implant overdentures: 12 ball; 13 telescopic attachment) Number of mandibular overdentures evaluated at 1 year: 23 (12 ball; 11 telescopic attachment) Number of mandibular overdentures evaluated at 2 years: 21 (11 ball; 10 telescopic attachment) Number of mandibular overdentures evaluated at 3 years: 16 (11 ball; 5 telescopic attachment) |
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Interventions | Mandibular 2‐implant overdentures ‐ unsplinted prosthodontic design Test group 1 (n = 12): Ankylos® (Dentsply Implants, Mannheim, Germany) ball attachments with connecting matrices were polymerized into spacers of the metal framework using a self‐curing resin (Pattern Resin LS, GC Europe, Leuven, Belgium) Test group 2 (n = 13): prefabricated telescopic (conus) attachments with connecting matrices were polymerized into spacers of the metal framework using a self‐curing resin (Pattern Resin LS, GC Europe, Leuven, Belgium) |
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Outcomes | Prosthodontic maintenance by general categorization Patient satisfaction (trial did not use validated criteria for this outcome) Data collection was performed on the day of overdenture delivery and after 1, 2 and 3 years |
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Notes | Location: Germany Funding source: this investigation was supported by a grant from Dentsply Implants, Mannheim, Germany Patient satisfaction data presented did not use validated criteria Authors contacted by email (7 February 2017): requested full prosthodontic maintenance categorization to facilitate data analysis ‐ no reply received Details of ethical approval: Freiburg Regional Council and the Ethics Committee of the Medical‐Center, Freiburg, Germany (Votum number: 105/04) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The patients were randomly assigned to the two trial groups consisting of ball and telescopic attachments" Comment: the trial does not include any description of how the sequence was generated |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was carried out by a statistician not involved in the study using sealed envelopes. The envelope containing information on the abutments to be used was opened by a dental nurse" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "As the prosthetic reconstruction was visible, blinding of the investigators was not possible" Comment: although participants and personnel were not blinded, we judge the risk of bias as low since it is an operative procedure and the outcomes are not likely to be influenced by lack of blinding of participants and personnel |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | The trial did not report blinding, however blinding is not possible due to the nature of the intervention, but we judge the risk of bias as low regarding prosthodontic maintenance due to being objective and is not likely to be influenced by lack of blinding |
Blinding of outcome assessment (detection bias) Patient‐reported outcomes | High risk | The trial did not report blinding, however blinding is not possible due to the nature of the intervention, but we judge the risk of bias as high regarding patient satisfaction due to being subjective and is likely to be influenced by lack of blinding |
Incomplete outcome data (attrition bias) All outcomes | High risk | Total losses: 9/25 (36%) Ball group losses: 1/12 Telescopic group losses: 8/13
In addition, 'per protocol' analysis was performed when analysing the patient satisfaction outcome |
Selective reporting (reporting bias) | Low risk | The trial protocol is not available, but we judge the risk of bias as low due to reporting key outcomes that are expected to be reported for such a trial |
Other bias | Low risk | None noted |