Horizontal Ridge Augmentation With or Without Autogenous Block Grafts

NCT03432702 | Completed

• 1 other identifier: 00013
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate dimensional bone alterations following horizontal ridge augmentation using guided bone regeneration (GBR) with or without autogenous block graft (ABG) for the rehabilitation of atrophic jaws with dental implants.

Conditions

Bone Regeneration; Bone Transplantation; Bone Substitutes; Cone-beam Computed Tomography; Dental Implants

Outcome Measures

Primary Outcomes (1)

• Changes in horizontal alveolar ridge width from pre-operatively (baseline) to 12 months after implant loading.

  Horizontal alveolar ridge changes in being assessed in the regenerated area. This outcome will be evaluated from pre-operatively (baseline), to 12 months after implant loading by measuring the alveolar ridge width at various points on the cross-sectional images using data obtained from CBCT scans.

  From pre-operatively (baseline) to 12 months after implant loading.

Secondary Outcomes (3)

• Implant failure

  At 6 months (T6), and at 18 months (T18) after implant placement.

• Complications

  6 months

• Regrafting necessity

  At 6 months (T6).

Study Arms (2)

Alveolar ridge augmentation without ABG

ACTIVE COMPARATOR

Horizontal ridge augmentation using guided bone regeneration without autogenous block graft (ABG)

Procedure: Horizontal ridge augmentation

Alveolar ridge augmentation with ABG

EXPERIMENTAL

Horizontal ridge augmentation using guided bone regeneration with autogenous block graft (ABG).

Procedure: Horizontal ridge augmentation

Interventions

Horizontal ridge augmentation PROCEDURE

Surgical procedures performed to provide the alveolar ridge with enough width and height to allow for the prosthetically driven implant placement.

Also known as: Alveolar ridge augmentation, Bone grafting

Alveolar ridge augmentation with ABG; Alveolar ridge augmentation without ABG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, who required an implant supported restoration in at least one site, with severe atrophy of the alveolar ridge in the horizontal plane (class III-IV atrophy according to Cawood and Howell classification),
• adequate oral hygiene
• no history of previous bone augmentation procedures at the implant site, and
• able to understand and sign an informed consent form.

You may not qualify if:

• uncontrolled systemic conditions, irradiation in the head and neck area, - immunosuppressed or immunocompromised,
• presented with oral disorders (such as lichen planus),
• treated or under treatment with intravenous amino-bisphosphonates,
• untreated periodontitis, poor oral hygiene and motivation,
• parafunctional habits,
• pregnant or lactating,
• drug or alcohol abuse,
• psychiatric disorders,
• a history (within the last 3 months) of using (at least weekly or more frequently) smokeless chewing tobacco, smoking a pipe, cigar or cigarette (at a rate of more than 10 cigarettes per day),
• acute/chronic infection/inflammation in the area, or
• an extraction with less than 3 months of healing

Sponsors & Collaborators

• Universidad Científica del Sur: lead
• NYU Langone Health: collaborator

Study Sites (1)

Periodontal Postgraduate Clinic at the Faculty of Dentistry, Científica del Sur University

Lima, Peru

Location

MeSH Terms

Interventions

Alveolar Ridge Augmentation; Bone Transplantation

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Transplantation

Study Officials

• Gerardo Mendoza-Azpur, DDS

  Científica del Sur University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome measurements will be recorded by an examiner, who will not participate in any study procedure, and will be blind to the allocated treatment. This blinded examiner will be trained and calibrated to perform measurements. A dentist who is blinded to the treatment protocol will performe all radiographic measurements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, prospective, controlled, parallel-armed, randomized clinical trial.

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 14, 2018
• Study Start: May 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: June 1, 2017
• Last Updated: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)