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OpenTrials
Completed

NCT Number: NCT04731545

Buccal Bone Resorption in Immediate SLActive Implant Placement Thin vs. Thick Buccal Bone

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

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

immediate implant placement

Device

Minimally traumatic tooth extraction, immediate implant placement and hard tissue grafting. loading after 3 months.

Primary outcomes

  1. Bucccal bone changes

    Time frame: 12 months post loading

    standardized Cone beam computed Tomography The radiograph will be taken preoperatively and 12 month after. The pre and post operative cone beams will be compared to each other observing any changes of the buccal bone at 2 , 4 and 6 mm from the crest, the measurements will be in mm

Secondary outcomes

  1. Implant stability

    Time frame: 3 months

    Ostell readings in isq (range from 55 till over 70) bleow 55 low stability over 55 till 65 moderate stability above 70 good stability

  2. Crestal bone changes

    Time frame: 12 months post loading

    Periapical radiograph the measurements will be taken from the platform of the implants. 3 readings will be taken one at the paltform one above and one below according to pattern and form of the resorption.

  3. Soft tissue thickness

    Time frame: 3 months

    Periodontal probe

  4. Post operative pain and swelling

    Time frame: 1 week

    Blinded assessment ( numerical score)

  5. Buccal bone thickness

    Time frame: 3 months

    Cone Beam Computed Topography

  6. Postsurgical satisfaction

    Time frame: 1 week

    Questionnaire

  7. Pink aesthetic score

    Time frame: 12 months post loading

    Pink esthetic score Scale 0 being the lowest and 14 highest attainable

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Institut Straumann AG

Registry information

Official study title

Evaluation of the Buccal Bone Resorption in Immediate SLActive Implant Placement in Thin vs. Thick Buccal Bone Plates: RCT

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Feb 1, 2021
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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