Horizontal Augmentation With Deproteinized Bovine Bone Mineral Alone or in Combination With Particulate Autogenous Bone

NCT04755166 | Unknown

• 1 other identifier: LRA humans
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Placement of oral implants is frequently compromised due to atrophy of the alveolar process. Lateral ridge augmentation with an autogenous bone block is frequently necessary to increase the width of the alveolar process before implant installation. However, harvesting of an autogenous bone block is associated with donor site morbidity. Consequently, bone substitutes alone or in combination with particulate autogenous bone graft are used increasingly to simplify the surgical procedure. Animal and human studies evaluating lateral ridge augmentation with Bio-Oss alone or in combination with particulate autogenous bone graft have demonstrated new bone formation and high implant survival. However, the optimal ratio of Bio-Oss and particulate autogenous bone graft for lateral ridge augmentation and long-term implant survival is unknown. Purpose: Test the H0-hypothesis of no difference in long-term implant survival, newly formed bone, volumetric stability of the graft, gained width of the alveolar process and patient satisfaction after lateral ridge augmentation with Bio-Oss alone or in combination with a diminutive amount of autogenous bone graft. Material and methods: lateral ridge augmentation will be performed in 20 adults with two different ratios of Bio-Oss and autogenous bone graft after a split mouth design. Clinical and radiological measurements will evaluate the long-term implant survival. Cone beam computer tomography (CBCT) will be obtained preoperatively, immediately postoperatively, prior to implant placement, 2 years after implant installation and 5 years after implant installation to estimate the volumetric changes of the augmented area. Moreover, the amount of newly formed bone will be estimated by histologic evaluation after implant placement. Conclusion: Long-term implant survival has never been evaluated after lateral ridge augmentation with Bio-Oss alone or in combination with a diminutive amount of autogenous bone graft.

Conditions

Edentulous Jaw

Keywords

Bone substitutes; Imaging-Three-Dimensional; alveolar ridge augmentation; dental implants; Bio-Oss; Guided bone regeneration

Outcome Measures

Primary Outcomes (6)

• Newly formed bone

  Amount of newly formed bone in the graft assessed by histological measurements

  10 months after treatment

• Height in mm

  Height of the augmented area assessed by radiological measurements

  10 months after treatment

• Volume in mm3

  Volume of the augmented area assessed by clinical and radiological measurements

  10 months after treatment

• Implant survival

  Survival of implants placed in the graft assessed by clinical and radiological measurements

  1 year after placement of the implants

• Implant survival

  Survival of implants placed in the graft assessed by clinical and radiological measurements

  3 year after placement of the implants

• Implant survival

  Survival of implants placed in the graft assessed by clinical and radiological measurements

  5 year after placement of the implants

Study Arms (2)

100:0

EXPERIMENTAL

100 % bone substitute, 0% autogenous bone

Procedure: Lateral ridge augmentation

90:10

EXPERIMENTAL

90% bone substitute, 10% autogenous bone

Procedure: Lateral ridge augmentation

Interventions

Lateral ridge augmentation PROCEDURE

100:0; 90:10

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Total or partial bilateral edentulism
• Horizontal bone width less than 4 mm at planned sites of implant installation or need of augmentation of aesthetic reasons for optimal implant placement

You may not qualify if:

• Uncontrolled systematic disease
• History of radiation in the area
• Smoking habits (free of smoking habits more than 1 month prior to treatment)
• Treatment with bisphosphonates
• Patients who cannot complete the 5-year observation period

Sponsors & Collaborators

• NU-Hospital Organization, Sweden: lead
• Aalborg University Hospital: collaborator

Study Sites (1)

NU Hospital Organization

Trollhättan, 46273, Sweden

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Hanna Aludden, DDS, PhD

  NU Hospital Organisation, Trollhättan, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 15, 2021
• Study Start: June 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

SE (1)