One-year performance of posterior narrow diameter implants in hyperglycemic and normo-glycemic patients-a pilot study

Abstract

Objectives: The aim of the study was to compare the performance of narrow diameter implants in patients with uncontrolled diabetes mellitus type 2 (T2DM) and normo-glycemic individuals during the first 12 months after implant loading.

Material and methods: In 16 T2DM patients with HbA1C > 6.5% (test group) and 16 normo-glycemic patients (HbA1C < 6.0%; control group), one to two narrow diameter tissue level implants were placed in the posterior maxilla or mandible. After 3-month lasting integration period, implants were loaded by fixed dentures. The clinical parameters probing depth (PD), bleeding on probing (BOP), attachment loss (CAL), recession and papilla bleeding index (PBI) were assessed manually at loading and after 12 months of function. The paired digital periapical radiographs were analyzed with regard to the change in marginal bone level (MBL) from baseline to 12 months' control. The mean values calculated for both patient groups were statistically analyzed. The technical complications were recorded.

Results: The T2DM group accounted 13 patients due to 3 dropouts. The overall implant survival rate after 12 months was 100%. The differences in means for the clinical parameters and the MBL were statistically non-significant between the T2DM and normo-glycemic patients for the short period of loaded function reported here. No technical complications were recorded.

Conclusions: The study demonstrated an encouraging clinical outcome with narrow diameter implants in patients with uncontrolled T2DM compared to non-diabetics after 12 months post loading. For the short observation period, no biological and technical complications were reported regardless the glycemic status.

Clinical relevance: Patients with HbA1C > 6.5% may benefit from the treatment with narrow diameter implants by avoiding complex surgical interventions with augmentation procedures.

Trial registration: Clinicaltrials.gov : NCT04630691.

Keywords: Marginal bone loss; Narrow diameter implants; SLActive surface; TiZr implants; Type 2 diabetes mellitus.

Fig. 1

Flowchart of study protocol. Visit 3 = 3 days, visit 4 = 10 days, visit 5 = 1 month, visit 6 = 3 months, visit 7 = 12 months. PPD probing pocket depth, cAL clinical attachment loss, BOP bleeding on probing, PBI papilla bleeding index

Fig. 2

Radiographic images disclosing the principle for MBL assessment at visit 7. a Adjustment of distortion coefficient. b Distal aspect of the implant. c Mesial aspect of the implant. For further measurements, the mean values from distal and mesial aspects were calculated

Fig. 3

Results for statistical evaluation of clinical measurements. a Clinical attachment loss. b Recession. c Probing pocket depth

Fig. 4

Descriptive statistics for a BOP and b papilla bleeding index (PBI)

Fig. 5

Results from radiographic evaluation of marginal bone loss (MBL). a Comparison of mean ΔMBL (MBL_12months − MBL_3months). b Descriptive statistics of mean MBL measurements at visits 6 and 7

Fig. 6

Plots for necessary sample size in a PD measurements and b MBL measurements