It was the aim of this 24-mo randomized controlled clinical trial to investigate whether the survival of a single median implant placed in the edentulous mandible to retain a complete denture is not compromised by immediate loading. Secondary outcomes were differences in prosthetic complications between the loading principles. Each of the 158 patients who received an implant was randomly assigned to the immediate loading group (n = 81) or the delayed loading group (n = 77). Recall visits were performed 1 mo after implant placement (for only the delayed loading group) and 1, 4, 12, and 24 mo after implant loading. Nine implants failed in the immediate loading group, all within the first 3 mo of implant loading, and 1 implant failed in the delayed loading group prior to loading. Noninferiority of implant survival of the immediate loading group, as compared with the delayed loading group, could not be shown (P = 0.81). Consistent with this result, a secondary analysis with Fisher exact test revealed that the observed difference in implant survival between the treatment groups was indeed statistically significant (P = 0.019). The most frequent prosthetic complications and maintenance interventions in the mandible were retention adjustments, denture fractures, pressure sores, and matrix exchanges. There was only 1 statistically significant difference between the groups regarding the parameter “fracture of the denture base in the ball attachment area” (P = 0.007). The results indicate that immediate loading of a single implant in the edentulous mandible reveals inferior survival than that of delayed loading and therefore should be considered only in exceptional cases (German Clinical Trials Register: DRKS00003730).

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To investigate whether there are differences in patients' denture satisfaction when an implant placed in the midline of the edentulous mandible is loaded either immediately or three months later, after second-stage surgery. One hundred and fifty-eight edentulous patients received a single implant in the midline of the mandible. After randomisation, it was loaded either immediately after implant placement (N = 81, group A) or three months later, after a submerged healing phase and a second-stage surgery (N = 77, group B). Patients' denture satisfaction aspects were assessed, using visual analogue scales (VAS), before treatment, one month after implant placement during the submerged healing phase (only group B) and one and four months after implant loading. The statistical analysis was performed using the Wilcoxon signed-rank and rank-sum tests. One month after loading, a significant improvement in comfort, function and stability of the mandibular denture could be observed in both groups (P ≤ 0·05). A slight but not significant improvement was found between one and four months after loading. Patients with second-stage surgery and delayed loading rated the stability and fit of the mandibular denture as significantly better than patients who had immediate loading. A single implant in the edentulous mandible significantly increased patients' denture satisfaction. After four months, stability and fit of the mandibular denture were considered better when a delayed loading protocol had been followed. A single mandibular implant in the edentulous mandible significantly increases patients' denture satisfaction, regardless of the loading protocol.

BackgroundOver the years, there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture. It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to 5 years without implant failures, when delayed loading was used. However, other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied. Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading.Methods/designThis prospective nine-center randomized controlled clinical trial is still ongoing. The final patient will complete the trial in 2016. In total, 180 edentulous patients between 60 and 89 years with sufficient complete dentures will receive one median implant in the edentulous mandible, which will retain the existing complete denture using a ball attachment. Loading of the median implant is either immediately after implant placement (experimental group) or delayed by 3 months of submerged healing at second-stage surgery (control group). Follow-up of patients will be performed for 24 months after implant loading. The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group. The secondary outcome measures encompass clinical, technical and subjective variables. The study was funded by the Deutsche Forschungsgemeinschaft (German research foundation, KE 477/8-1).DiscussionThis multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded. If viable, this treatment option will strongly improve everyday dental practice.Trial registrationThe trial has been registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00003730 since 23 August 2012. (http://www.germanctr.de).