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Tooth Roots for Lateral Alveolar Ridge Augmentation

Not Applicable
Conditions
Bone Atrophy, Alveolar
Interventions
Procedure: tooth root augmentation
Registration Number
NCT04678674
Lead Sponsor
St. Catherine Specialty Hospital
Brief Summary

A deficient alveolar ridge segment in prepara¬tion for implant placement can be regenerated by several techniques. The type of graft material for each patient depends on many factors such as the anatomy, the morphology of the bone defect, type of prosthodontic rehabilitation and patient or clinician preferences. Bone graft material should have three properties that made it ideal: a) osteoconduction, it provides scaffolds for bone regeneration; b) osteoinduction, it promotes the recruitment of bone-forming cells and formation of bone and c) osteogenesis, induction of cells in the graft to promote regeneration of the bone.

Despite of the development of different types of graft material, autogenous bone is still the gold standard for bone augmentation because it exhibits these three mentioned properties. Although it has many advantages, autologous bone has some disadvantages such as high resorption rate up to 50 %, limited source and donor site morbidity. Allografts, xenografts and alloplastic bone graft are materials that are used in everyday practice and over long period, but their disadvantages are numerous in comparison with autologous bone. Allografts can be carrier of some disease and show lack of osteoproliferation, while alloplasts and xenografts show only osteoconduction. According to these facts, it is obvious that there is a need for development an alternative graft material that will surpass these disadvantages.The reconstruction of deficient alveolar ridge defect by the lateral bone augmentation prior to the dental implant placement is predictable and commonly used method. Except animal studies, recent clinical studies showed that there is no difference in the osseointegration of titanium implants in deficient alveolar ridges reconstructed with autogenous cortical bone blocks or autogenous teeth.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
Inclusion Criteria
  • age 18 to 60 years
  • candidate for lateral ridge augmentation
  • insufficient bone ridge width at the recipient site for implant placement
  • sufficient bone height at the recipient site for implant placement and (e)
  • healthy oral mucosa
  • at least 2 mm keratinized tissue
Exclusion Criteria
  • general contraindications for dental and/or surgical treatments
  • inflammatory and autoimmune disease of the oral cavity,
  • uncontrolled diabetes (HbA1c > 7%)
  • history of chemotherapy or radiotherapy within the past five years,
  • previous immunosuppressant, bisphosphonate or high- dose corticosteroid therapy
  • smokers
  • pregnant or lactating women

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
bone defect surgerytooth root augmentationaugmentation on insufficient alveolar ridges with autologous teeth will be performed (wisdom tooth or periodontally compromised tooth)
Primary Outcome Measures
NameTimeMethod
The primary endpoint was defined as the clinical width (CW) of the alveolar ridge6 months

The primary endpoint was defined as the clinical width (CW) of the alveolar ridge being sufficient for the placement of an adequately dimensioned dental implant without the need for a secondary grafting at 6 months after surgery in either group. CW was assessed before (CWa) and after (CWb) augmentation healing period of 6 months in cone-beam computed tomography (CBCT) scans.

Measurements were performed to the nearest 0.5mm below the crest using a CBCT.

Secondary Outcome Measures
NameTimeMethod
soft tissue dehiscences6 months

yes/no for secondary wound healing

gain in ridge width (CWg)6 months

CWg (mm) = CWb ( ridge after surgery in mm)- CWa ( ridge before surgery in mm)

wound infections6 months

monitoring whether there is an increased incidence of inflammatory conditions after the specified procedure

Periimplant tissue stability of augmented sites after prosthetic rehabilitation12 months

Usage of periimplant tissue parameters for assessing the conditions around implants placed in augmented sites using pink esthetic score (PES) that evaluates the esthetic outcome of soft tissue around implant-supported single crowns by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency.

Trial Locations

Locations (1)

St. Catherine Specialty Hospital

🇭🇷

Zagreb, Croatia

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