Soft Tissue Healing around immediate implants with standard versus customized healing abutment. One-year outcomes of an ongoing randomized clinical trial

15442 ORAL COMMUNICATION BASIC RESEARCH

Background

Immediate implant placement into fresh extraction sockets is generally considered a reliable procedure that offers several clinical advantages.

Aim/Hypothesis

The primary aim of this study was to evaluate and compare the soft tissues changes around immediate implants that received - during the first 4 months of healing - a customized (test) or a standard (control) healing abutment. The secondary aims of this study were to evaluate and compare marginal bone changes for the test and control groups. This study is a 1-year preliminary assessment of an ongoing study.

Materials and Methods

The present study was designed as a parallel arm, single-blind, randomized, and controlled clinical trial to compare the clinical and radiographic outcomes of immediate implants that received for the first 4-month healing period a standard (control) or a customised (test) healing abutments. The Ethical Local Committee at Geneva, Switzerland approved the study (Approval number- 2017-01483). All patients who required single-tooth extraction and immediate implant placement in the anterior region of the jaws, who had a type 1 extraction, were 18 years old or older, and were able to understand and sign a consent form, were eligible for the study. Bone Level Tapered implants (Straumann®) were inserted immediately after tooth extraction and had a secondary soft tissue healing with a standard or customised healing abutment. Patientsí information such as age, gender, smoking habits and those related to surgery such as reason for tooth extraction, type of extraction socket, implant position and Insertion Torque value at implant placement, were recorded.

Results

In total 36 patients were randomized in the 2 experimental groups and received their allocated treatment. No prosthetic or implant failure was registered during the study period with a 100% of survival rate. Primary Outcomes- The mean total PES score was 8.7 at T0 and 8.7 at 12-month follow-up for the test group; on the other hand the mean total PES score was 8.8 at T0 and 8.2 at 12-month follow-up for the control group. Remarkably, only the distal papilla parameter of the PES showed a significant (P = 0.0002) better value (1.6 ± 0.5) in the customized group. When considering the Papilla Index (PI), at 12-month follow-up the mesial papilla accounted for 2.4 ± 0.5 and 2.0 ± 0.5 in the test and control groups respectively, this difference was statistically significant (P = 0.0150); accordingly, the distal papilla accounted for 2.6 ± 0.6 and 1.6 ± 0.6 in the customized and standard groups, this difference was statistically significant (P = 0.0002). Secondary Outcomes- The mean marginal bone loss at 12-month follow-up was 0.3 mm for the test group versus 0.6 mm for the control group, this difference was not significant (P = 0.0787). Meanwhile, in the test group at 12-month follow-up the marginal bone loss at mesial sites amounted to 0.0 mm versus 0.6 mm in the control group, this difference resulted to be significantly different (P = 0.0014). The mid-facial mucosal level at 12-month examination showed a recession of 0.2 ± 0.4 mm for the customized group, in contrast the standard group showed a gain of mucosal level of 0.1 ± 0.5 mm. This difference was significant (P = 0.0129).

Conclusion and Clinical Implications

The present findings suggested that customized abutments showed a trend towards better management of soft and hard tissues than standard healing abutments in case of immediate implant placement.