Prospective cohort study to evaluate narrow diameter implants for restoration of a missing lateral incisor in patients with a cleft palate: One-year results.

STATEMENT OF PROBLEM:Patients diagnosed with a cleft palate often have a congenitally missing maxillary lateral incisor. The congenital cleft presents the practitioner with challenges including the quantity and quality of bone, a surgically managed cleft correction, and limited clinical space. PURPOSE:The purpose of the present prospective investigation was to report preliminary results at the 1-year follow-up for this planned 5-year investigation of narrow diameter implants used to restore a missing lateral incisor in patients with a cleft palate. MATERIAL AND METHODS:Fourteen study participants with a cleft palate and a missing maxillary lateral incisor were enrolled based on established criteria. Narrow diameter implants (AstraTech OsseoSpeed TX 3.0S and 3.5 mm) were placed by using a 2-stage protocol and restored. All study participants received an Atlantis abutment and a cement-retained crown. Four probing depth measurements and bleeding on probing were measured at baseline and at 1 year. Probing depth measurements were evaluated using a 2-way repeated measures ANOVA with Tukey-Kramer multiple comparisons tests. Radiographic marginal bone loss was measured at 1-year by using a digital subtraction technique and evaluated by using a repeated measures ANOVA. Pretreatment cone beam computed tomography (CBCT) images were used to measure a mean gray level that was proportional to bone mineral density (BMD) in the implant site. One-way mixed ANOVA was used to compare the mean gray level and average implant stability quotient (ISQ) loading. A Pearson correlation was also tested between those parameters (α=.05) for each statistical analysis. RESULTS:The mean marginal bone loss at 1 year was 0.601 ±0.48 mm. Regarding probing depth measurements, a 2-way repeated measures ANOVA found both the location (P=.012) and time (P=.009) were significant. The Tukey-Kramer multiple comparisons test showed a significant difference between the buccal and distal site (P=.006) from baseline to 1-year follow-up. CONCLUSIONS:Narrow diameter implants are a reliable treatment for replacing a missing lateral incisor in patients with a cleft palate at 1 year, with an implant survival rate of 100% and implant success rate of 94% using the established criteria. A negative association was found between the bone mineral density and the implant stability in the alveolar cleft site of a patient with a cleft palate. The peri-implant soft tissue probe depths exhibited significant change during the first year.