Crestal Bone Changes Following Equi-crestal Versus Subcrestal Implant Placement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Subcrestal implant placement, Crestal implant placement.
- Who it may be relevant to
- Registry conditions: Implant Therapy, Augmentation, Alveolar Ridge. Basic parameters: 21 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Radiographic Evaluation of Crestal Bone Changes Following Equi-crestal Versus Subcrestal Implant Placement in Mandibular Posterior Augmented Ridge. A Randomized Controlled Clinical Trial.
Overview
Statement of problem: The stability of peri-implant bone is a crucial factor for the long-term success of dental implants, where crestal bone plays a significant role in both the primary as well as the long- term implant stability. A bone loss of 1.5 mm during the first year of loading has been acceptable according to the early standards. However, more bone stability can be expected with the development in implant designs and surfaces over the past decades. Aim of the study: the aim of this study is to radiographically assess the crestal bone changes following delayed implant placement in mandibular previously augmented posterior sites, comparing cases with equicrestal implant placement with subcrestal implant placement
Detailed description
Statement of problem: The stability of peri-implant bone is a crucial factor for the long-term success of dental implants, where crestal bone plays a significant role in both the primary as well as the long- term implant stability. A bone loss of 1.5 mm during the first year of loading has been acceptable according to the early standards. However, more bone stability can be expected with the development in implant designs and surfaces over the past decades.
Aim of the study: the aim of this study is to radiographically assess the crestal bone changes following delayed implant placement in mandibular previously augmented posterior sites, comparing cases with equicrestal implant placement with subcrestal implant placement.
Materials and methods: This prospective, parallel, randomized controlled clinical trial will have 36 participants who need implant placement at the posterior mandibular area where they previously received horizontal bone augmentation. They will be randomly allocated into 2 groups, where group A (test) will receive dental implant placed subcrestally and group B (control) will receive implant placed equicrestally. Crestal bone loss will be assessed by periapical radiographs at implant placement (T0), 3 months (T3), 6 months (T6), 12 months (T12) and 18 months (T18) following implant placement. Keratinized tissue width, and soft tissue thickness will be measured clinically by periodontal probe at the same time points. Buccal bone changes will be evaluated at 18 months compared with the preoperative cone beam computed tomography by fusion module. Patient satisfaction will be recorded at the end of the trial.
Interventions
- Procedure Subcrestal implant placement
Delayed implant placement 2 mm subcrestally in missing mandibular posterior site. - Procedure Crestal implant placement
Delayed implant placement equicrestally in missing mandibular posterior site.
Primary outcome measures
- Crestal bone changes [Time frame: at baseline,3, 6 ,12 and 18 months]
Secondary outcome measures (2)
- Keratinized tissue width [Time frame: at baseline, 3,6,12 and 18 months]
- Patient satisfaction [Time frame: at baseline, 6 ,12 and 18 months]
Eligibility criteria
Inclusion criteria
- Patients older than 21 years.
- Patients having augmented (by 50/50 particulate xenograft and autogenous bone) edentulous posterior site with vertical bone height of > 10 mm in the mandible with a width of ridge ≥ 7 mm
- Adequate Inter-arch space for implant placement
- Favorable occlusion (no traumatic occlusion).
- Good oral hygiene.•Accepts 18 months follow-up period (cooperative patient)
- The patient provides informed consent.
Exclusion criteria
- Patients with inadequate bone volume and/ or quality
- Patients with remaining roots or with signs of acute infection related to the area of interest.
- Patients having systemic conditions that interfere with normal wound healing
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits .
- Smoker patients.
- Pregnant women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Misr International University — Cairo
Identifiers
NCT: NCT06760442 · Crestal Bone Changes