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OpenTrials
Completed

NCT Number: NCT06515509

Evaluation of the Dimensional Alveolar Bone Changes in Immediate Post Extraction Implant Placement

The aim of this study was to evaluate the dimensional alveolar bone changes in immediate post extraction implant placement with loading compared to immediate post extraction implant placement without loading in the maxillary premolar area . The main question it aims to answer is : Can immediate post extraction implant placement in the maxillary premolar area with loading achieve better alveolar bone dimensions than without loading?

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 1. Patients who have at least one non restorable tooth in the maxillary premolar area that needs to be extracted.
  • Patients with healthy systemic condition. 3. Patients aged from 20 to 45 years old. 4. Buccal bone thickness should be at least 1mm. (Morton et al., 2014) 5. Availability of bone apical and palatal to the socket to provide primary stability.(Morton et al., 2014) 6. Good oral hygiene.(Wiesner et al., 2010) 7. Accepts one year follow-up period (cooperative patients) Patient provides an informed consent.
  • Adequate Inter-arch space for implant placement. 9. Favorable occlusion (no traumatic occlusion)

Exclusion criteria

  • 1. Patients with signs of acute infection related to the area of interest. 2. Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al., 2006).
  • Current and former smokers (Lambert, Morris and Ochi, 2000) 4. Pregnant females.

Treatment and study plan

immediate implant placement with or without loading

Procedure

immediate implant placement with or without loading

Primary outcomes

  1. Height of alveolar bone crest

    Time frame: 6 months

    After the implants are placed, a series of digital radiographs are obtained at 0 , 3, and 6 months duration to study the changes in the amount of crestal bone level.

Secondary outcomes

  1. Implant stability

    Time frame: 6 months

    Implant stability quotient (ISQ) values were measured with an Osstell® (Integration Diagnostics AB, Gothenburg, Sweden)

  2. Alveolar bone width

    Time frame: 6 months

    (CBCT) images are used for evaluation of alveolar bone width around all implant sides all over. At 0. 3, 6 month postoperative by using superimposition and subtraction method

  3. post-surgical patient satisfaction

    Time frame: 6 months

    Post-Surgical Patient Satisfaction Questionnaire (PSPSQ) composed of 3 questions is filled by the patient and numerical score is obtained

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of the Dimensional Alveolar Bone Changes in Immediate Post Extraction Implant Placement in the Maxillary Premolar Area With or Without Loading: A Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 23, 2024
Registry last updated
Jul 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.