Background
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The proportion of referred patients that were eligible to participate, consented to the trial and provided data at all time-points;
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Whether masticatory functional ability could be measured using a validated ‘gummy jelly’ chewing test;
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The completeness and variability of using different instruments to collect data on pain, QoL, implant failure; and
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How to collect and measure costs
Methods
Design and eligibility criteria
Randomisation
Treatment procedures
Mini-implant (MI)
Conventional implant (CI)
Outcomes
Baseline | At operation | 24 h | 1 week | 2 months | 6 months | |
---|---|---|---|---|---|---|
Anxiety: Modified Dental Anxiety Scale [64] | X | |||||
Quality of Life: SF-12 [67] | X | X | X | |||
Satisfaction with dentures: The University of Newcastle ‘Assessment of Prosthesis’ questionnaire | X | X | X | |||
Masticatory function: ‘gummy jelly’ chewing test | X | X | X | |||
Pain: Visual Analogue Scale (VAS) or Verbal Rating Scale (VRS) (0–10) | X | X | X | |||
Use of analgesics (professionally and self prescribed) and antibiotics | X | X | X | X | X | |
Direct costs-staffinga
| X | |||||
Direct costs-equipmenta
| X | |||||
Direct costs-consumablesa
| X | |||||
Indirect costsa
| X | X | ||||
Healthcare utilisationa
| X | X | X | X | X | |
Assessment of adverse eventsa
| X | X | X | X | X | |
Assessment for possible implant failure | X | X | X |
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The feasibility of recruitment was measured in terms of eligibility (the proportion of eligible patients from the number of screened patients), recruitment (the proportion of recruited patients from the number of eligible patients), and whether the required sample size could be met within the designated 12-month recruitment period. The success of patient retention was measured in terms of compliance with randomisation (the proportion of participants receiving their allocated treatment) completeness of follow-up (the proportion of patients providing 6 month follow up data). The denominator was the number of patients randomised.
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The feasibility of using masticatory efficiency as an effectiveness outcome was assessed as the number of ‘gummy jelly’ samples that were provided, and were able to be analysed.
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The appropriateness of the different outcome measures was assessed quantitatively in terms of proportion of completed questionnaires, and qualitatively in variation, absence of floor or ceiling effects and variability of responses over time.
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The feasibility and appropriateness of collecting cost information was assessed based on the proportions of completed patient questionnaires (patient costs) and completed health care costs, and the recording of unanticipated resource use.
Sample size
Statistical analysis
Results
Mini implants (n = 22) | Conventional implants (n = 23) | Total (n = 45) | |
---|---|---|---|
Age | 68.5 (9.5) 68.5, 63 to 74 52 to 88 | 68.1 (8.5) 71, 61 to 74 48 to 79 | 68.3 (8.9) 70, 62 to 74 48 to 88 |
Gender | 10 male (45.5%) | 9 male (39.1%) | 19 male (42.2%) |
Years edentulous | 26.0 (20.8) 32, 3 to 45 1 to 58 | 20.2 (17.7) 14, 5 to 38 1 to 57 | 23.1 (19.3) 15, 5 to 40 1 to 58 |
Anxiety (Modified Dental Anxiety Scale) | 10.8 (3.8) 11, 8 to 14 5 to 17 | 11.6 (6.6) 9, 6 to 15 5 to 25 | 11.2 (5.4) 10, 7 to 14 5 to 25 |
Mini implants | Conventional implants | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Outcome | Baseline (n = 22) | Operation (n = 22) | 24 h (n = 22) | 1 week (n = 22) | 2 months (n = 20) | 6 months (n = 19) | Baseline (n = 23) | Operation (n = 23) | 24 h (n = 23) | 1 week (n = 23) | 2 months (n = 23) | 6 months (n = 22) |
Glucose Mean (sd) Median (IQR) | 145.18 (54.00) | 193.95 (86.84) | 198.84 (111.76) | 185.35 (81.02) | 189.21 (87.11) | 187.86 (74.21) | ||||||
132 (109 to 184) | 172 (152 to 204) | 170 (99 to 241) | 164 (126 to 230) | 161 (138 to 208) | 180.5 (135 to 246) | |||||||
Paina
Mean (sd) Median (IQR) | 6.5 (5.5) | 3.05 (2.6) | 16.8 (19.38) | 11.58 (14.6) | 4.3 (3.2) | 38 (32.2) | ||||||
4 (3 to 10) | 3 (0 to 5) | 6.5 (2 to 27) | 5 (3 to 15) | 3 (1 to 7) | 37 (7 to 69) | |||||||
Analgesic consumption | 15/22 (68.18%) | 8/22 (36.36%) | 20/23 (86.96%) | 16/23 (69.57%) | ||||||||
OHIP-20bMean (sd) Median (IQR) | 76.5 (20.1) | 66.5 (28.3) | 40.9 (18.1) | 83.3 (23.1) | 79.6 (24.9) | 56.2 (29.6) | ||||||
78.5 (60 to 92) | 65 (43 to 80) | 36 (25 to 58) | 81 (64 to 100) | 82 (58 to 105) | 43 (29 to 81) | |||||||
Affects general healthc
| 14/22 (63.6%) | 5/20 (25%) | 5/19 (26.3%) | 12/23 (52.2%) | 7/23 (30.4%) | 4/22 (18.2%) | ||||||
Implant Failure | 1 | 0 | 0 | 0 |
NHS cost | Patient cost | NHS and patient cost | |
---|---|---|---|
Mini implants | |||
Mean | 296.09 | 193.22 | 480.60 |
Sd | 126.93 | 119.91 | 249.89 |
Count | 22 | 7 | 7 |
Median | 237.33 | 178.58 | 389.19 |
IQR | 218.19 to 370.16 | 112.70 to 248.09 | 330.81 to 635.33 |
Range | 194.41 to 736.72 | 62.73 to 430.23 | 277.90 to 984.82 |
Conventional implants | |||
Mean | 688.30 | 155.57 | 813.99 |
Sd | 124.17 | 70.68 | 93.62 |
Count | 23 | 8 | 8 |
Median | 655.31 | 157.89 | 823.17 |
IQR | 628.13 to 687.45 | 106.73 to 198.26 | 750.10 to 860.51 |
Range | 585.75 to 1189.69 | 54.07 to 264.72 | 676.53 to 967.84 |
Overall | |||
Mean | 496.56 | 173.14 | 658.41 |
Sd | 233.90 | 95.07 | 246.54 |
Count | 45 | 15 | 15 |
Median | 607.63 | 170.26 | 696.81 |
IQR | 239.68 to 656.03 | 112.70 to 222.36 | 389.19 to 847.45 |
Range | 194.41 to 1189.69 | 54.07 to 430.23 | 277.90 to 984.82 |
Mini implants | Conventional implants | |||||||
---|---|---|---|---|---|---|---|---|
Outcome | Baseline (n = 22) | 2 months (n = 20) | 6 months (n = 19) | Baseline (complete cases, n = 19) | Baseline (n = 23) | 2 months (n = 23) | 6 months (n = 22) | Baseline (complete cases, n = 22) |
EQ-5D Mean (sd) Median (IQR) | 0.7224 (0.3276) | 0.7289 (0.3598) | 0.7127 (0.2968) | 0.7146 (0.3524) | 0.6401 (0.3639) | 0.5840 (0.4489) | 0.6241 (0.3715) | 0.6458 (0.3715) |
0.7960 (0.7250 to 1.0000) | 0.8050 (0.6380 to 1.000) | 0.7270 (0.6200 to 1.0000) | 0.7960 (0.7250 to 1.0000) | 0.6560 (0.5160 to 1.0000) | 0.7960 (0.0880 to 1.0000) | 0.8220 (0.1890 to 1.0000) | 0.6905 (0.5160 to 1.0000) | |
SF-6D Mean (sd) Median (IQR) | 0.7153 (0.2060) | 0.6844 (0.2465) | 0.6943 (0.2404) | 0.7220 (0.2149) | 0.6714 (0.2158) | 0.6720 (0.2130) | 0.7263 (0.2117) | 0.6767 (0.2193) |
0.7670 (0.6150 to 0.9220) | 0.7580 (0.4055 to 0.8715) | 0.8000 (0.4070 to 0.8800) | 0.8000 (0.6150 to 0.9220) | 0.7190 (0.4530 to 0.8630) | 0.6900 (0.4670 to 0.8630) | 0.8000 (0.4670 to 0.9220) | 0.7645 (0.4530 to 0.8630) |