A randomized controlled clinical trial comparing the effects of three loading protocols on dental implant stability.

PURPOSE The primary goal of this stratified randomized controlled trial (SRCT) was to compare the stability of dental implants placed under three different loading regimens during the first 16 weeks of healing following implant placement. Implants were loaded immediately, early (6 weeks), or with conventional/delayed timing (12 weeks). Secondary outcomes were to compare marginal bone adaptation for 3 years after placement. MATERIALS AND METHODS Single posterior implant sites in the maxilla or mandible were examined. The insertion torque value was the primary determinant of load assignment. Resonance frequency analysis was performed at follow-up appointments for the first 16 weeks (with results provided as implant stability quotients [ISQs]). Marginal bone levels were assessed via radiographs. RESULTS Forty patients each received a single 4.0-mm diameter dental implant between 2004 and 2007. One implant failure occurred in Lekholm and Zarb type 4 bone with insertion torque value (ITV) of < 8.1 Ncm; the cumulative success rate was 97.5%. All implants, when classified by bone and loading type, increased in stability over time, with a minor reduction of 1.3 ISQ units seen at 4 weeks in the immediate loading group. The mean marginal bone loss over 3 years was 0.22 mm. The mean ITVs at implant placement for bone types 1 and 2 (grouped together), 3, and 4 were 32, 17, and 10, respectively, and were significantly different (P < .05). CONCLUSIONS ITV was a good objective measure of bone type. Using an ITV of 20 Ncm as the determinant for immediate loading and an ITV of 10 Ncm or greater as the determinant for early loading provided long-term success for this implant and led to no negative changes in tissue response. All bone type groups and loading groups showed no reduction in stability during the first 4 months of healing.