Autogenous Bone Block versus Collagenated Xenogeneic Bone Block to evaluate treatment concept for reconstruction of atrophic alveolar ridge: a non-inferiority randomized clinical trial

Not Applicable

• Conditions: k08.2; Tooth Loss; Atrophied alveolar ridge.; K08.1

• Registration Number: RBR-3vn9c5q
• Lead Sponsor: Faculdade de Odontologia da Universidade de São Paulo

Brief Summary

Patient recruitment started in August 2017 and ended in December 2020. A total of 155 patients were screened. Out of these, 64 patients entered the clinical trial having fulfilled all inclusion and exclusion criteria. Thirty-two patients were allocated to group CXBB and 32 patients to group ABB. A detailed description on patient recruitment and demographics is displayed in Table 1 and Figure 3. The median thickness of the alveolar ridge at baseline were 2.65± 0.69 mm (CXBB) and 2.95 ±0.76 mm (ABB), with no differences between the groups (fazer a estatistica com Mann-Whitney e acrescentar o valor de p). CXBB was non-inferior to ABB for the increase of atrophied ridge width preceding implant placement (CXBB mean increase was 3.69 ± 1.55 mm; ABB mean increase was 3. 51 ± 1.23 mm) (Table 2 and Figure 4). Secondary performance endpoints demonstrated comparable results for CXBB and ABB in terms of possibility to place an implant (CXBB 96.7%; ABB 100%, p>0,05 ), need to perform a secondary bone augmentation at the time of implant placement (CXBB 13%; ABB 10% , p>0,05 ) and graft loss (CXBB 3.3%; ABB 0%, p>0,05 ). Secondary safety endpoints also showed comparable results for CXBB and bone block in terms of total number of adverse events (CXBB 68.8%; ABB 68.8% ) and occurrence of dehiscence after augmentation (CXBB 31.3%; ABB 37.5% , p>0,05 ) and at implant placement (CXBB 12.5%; ABB 21.9%, p>0,05 ). With regard to early implant failures, exploratory analysis did not suggest differences between treatment groups, considering the patient (p = 0.20) or the dental implant (p = 0.20) as the statistical unit. The total duration of surgery for the CXBB group (55 ± 17 min) was significantly shorter than for the ABB group (121 ± 29 min) (p < 0.0001). Moreover, consumption of analgesic medications was significantly lower in the CXBB group (5.6 ± 8.3) than in the ABB group (11.9 ± 11.6) (p < 0.05). Finally, pain (VAS) scores, from day one to day ten after augmentation procedure, were also significantly lower in the CXBB group (7.7 ± 9.5) than in the ABB group (16 ± 16.4) .

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-12-28
• Study Start: 2021-09-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Written informed consent; Age 18 years or older; Partial edentulism (up to 4 missing adjacent teeth); Atrophied alveolar ridge with one or more adjacent missing teeth; Atrophied alveolar ridge with residual ridge width of = 4 mm; Sufficient bone height at the surgical site for implant placement

Exclusion Criteria

General contraindications for dental and/or surgical treatments; Periodontitis or Peri-implantitis; Probing depth > 4mm at the adjacent teeth; Inadequate oral hygiene (PI>1); Knife-edge morphology of the alveolar ridge; Implants adjacent to the surgical site; Inflammatory disease of oral cavity; Immunological impairment; Allergy to collagen; Diabetes; History of myeloma, respiratory tract cancer, breast cancer, prostate cancer or kidney cancer requiring chemotherapy or radiotherapy within the past five years; Previous, concurrent or planned radiotherapy of head area; Concurrent or previous immunosuppressant, bisphosphonate, high-dose or long-term corticosteroid therapy; Smokers or subjects who did not quit smoking at least 3 months prior to the surgery; Pregnant or lactating women; Women of childbearing age, who are not using a highly effective method of birth control; Participation in an investigational device, drug or biologics study within the last 26 weeks prior to the study start; Participation in any other clinical investigation during the study

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome was the clinical gain in the width of the ridge 2 mm below the alveolar ridge in 30 weeks after the increase in the horizontal ridge. The ridge width gain (mm) was defined as the ridge width measured at implant placement minus the ridge width measured at the baseline before the bone graft.;Possibility to place an implant after graft surgery.<br>

Secondary Outcome Measures

Name	Time	Method
-Early implant failures.;-Need for additional guided bone regeneration in implant placement, assessed through the presence of thin bone remaining in the bone walls surrounding the implant, according to the operator's criteria. ;Postoperative complications, assessed during the postoperative period, through photos, clinical measures in the control consultations and patient reports. <br>;-Surgery time, measured by the time that was measured in minutes using a timed clock. ;-Patient-centered outcomes, such as pain and, quantity of analgesics, quality related to oral health of life (OHIP-14) and satisfaction with the result of the treatment were, measured through specific questionnaires. <br>