Clinical trial NCT04731545: Buccal Bone Resorption in Immediate SLActive Implant Placement Thin vs. Thick Buccal Bone
Official title: Evaluation of the Buccal Bone Resorption in Immediate SLActive Implant Placement in Thin vs. Thick Buccal Bone Plates: RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Immediate Implant
Keywords: immediate implant
esthetic zone
buccal plate
SLActive
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Institut Straumann AG
First posted: 2021-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The utilization of SLActive implants which allow more rapid osseointgeration with 3 to 4 weeks. will be placed in thin buccal bone as immediate implants to determine the resorption compared to thick buccal bone

Detailed description: With the increased demand for aesthetics and the expectation of immediate tooth replacement, improving the treatment options in case with hopeless teeth in the esthetic zone by immediate implants is a need by both practitioners and patients.

Current guidelines, today, restricting such treatment to only thick (+ or = 1mm) buccal bone plates. However, the literature shows that less than 10% of the community have such criteria, making it a high risk but needed procedure.

Soft tissue and bone remodelling after extraction is an inescapable fact. Immediate implant placement cannot prevent soft tissue and bone remodeling around implants (Araújo et al. 2005, Chen et al. 2009), but implant surface treatment and modifications might enhance the maintainability of the supporting structures around the dental implant due to its faster integration, better stimulating the vascular components at the site. This could be tested by the crestal and buccal bone changes, pink esthetic score and ostell readings.

Eligibility criteria: Inclusion Criteria:

1. Single bounded irrestorable tooth in the esthetic zone that needs to be extracted.
2. Healthy systemic condition.
3. Type I socket with a minimum of 1mm of buccal bone thickness prior to extraction. (Morton et al., 2014)
4. Sufficient bone apical to the socket for implant primary stability. (Morton et al., 2014)
5. Good oral hygiene.
6. Patient accepts a minimum of three-year follow-up period (cooperative patients).

Exclusion Criteria:

1. Signs of acute infection related to the area of interest.
2. Patients with parafunctional habits (Lobbezoo et al. 2006 and Roelhing et al. 2016).
3. Smokers (Lambert et al. 2000).
4. Pregnant females.

Primary outcomes:
measure: Bucccal bone changes
timeFrame: 12 months post loading
Secondary outcomes:
measure: Implant stability
timeFrame: 3 months
measure: Crestal bone changes
timeFrame: 12 months post loading
measure: Soft tissue thickness
timeFrame: 3 months
measure: Post operative pain and swelling
timeFrame: 1 week
measure: Buccal bone thickness
timeFrame: 3 months
measure: Postsurgical satisfaction
timeFrame: 1 week
measure: Pink aesthetic score
timeFrame: 12 months post loading
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine Cairo University
Study officials:
References: