Clinical trial NCT06760442: Crestal Bone Changes Following Equi-crestal Versus Subcrestal Implant Placement
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Implant Therapy
Augmentation, Alveolar Ridge
Keywords: crestal bone level changes
subcrestal implant position
crestal implant position
augmented ridge
dental implants
Lead sponsor: Misr International University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Crestal bone changes
timeFrame: at baseline,3, 6 ,12 and 18 months
Secondary outcomes:
measure: Keratinized tissue width
timeFrame: at baseline, 3,6,12 and 18 months
measure: Patient satisfaction
timeFrame: at baseline, 6 ,12 and 18 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Misr International University
Study officials:
affiliation: Misr International University
name: hani el nahas professor, Professor
role: STUDY_CHAIR
References: