Horizontal Ridge Augmentation With or Without Autogenous Block Grafts

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03432702
• Date of registration: 31/01/2018
• Prospective Registration: No
• Primary sponsor: Universidad Científica del Sur
• Public title: Horizontal Ridge Augmentation With or Without Autogenous Block Grafts
• Scientific title: Horizontal Ridge Augmentation With Guided Bone Regeneration Using Particulate Xenogenic Bone Substitutes With or Without Autogenous Block Grafts: A Randomized Controlled Trial
• Date of first enrolment: May 1, 2012
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03432702
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Peru

Contacts

• Name: Gerardo Mendoza-Azpur, DDS
• Affiliation: Científica del Sur University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 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.

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bone Regeneration

Bone Transplantation

Dental Implants

Bone Substitutes

Cone-beam Computed Tomography

Intervention(s)

Procedure: Horizontal ridge augmentation

Primary Outcome(s)

Changes in horizontal alveolar ridge width from pre-operatively (baseline) to 12 months after implant loading. [Time Frame: From pre-operatively (baseline) to 12 months after implant loading.]

Secondary Outcome(s)

Regrafting necessity [Time Frame: At 6 months (T6).]

Complications [Time Frame: 6 months]

Implant failure [Time Frame: At 6 months (T6), and at 18 months (T18) after implant placement.]

Secondary ID(s)

00013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

NYU Langone Health