Clinical trial NCT06515509: Evaluation of the Dimensional Alveolar Bone Changes in Immediate Post Extraction Implant Placement
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immediate Implant With Loading
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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?


Eligibility criteria: Inclusion Criteria:

* 1. Patients who have at least one non restorable tooth in the maxillary premolar area that needs to be extracted.

  2. 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.

  8. 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).

3. Current and former smokers (Lambert, Morris and Ochi, 2000) 4. Pregnant females.

Primary outcomes:
measure: Height of alveolar bone crest
timeFrame: 6 months
Secondary outcomes:
measure: Implant stability
timeFrame: 6 months
measure: Alveolar bone width
timeFrame: 6 months
measure: post-surgical patient satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
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citation: Albrektsson T, Branemark PI, Hansson HA, Lindstrom J. Osseointegrated titanium implants. Requirements for ensuring a long-lasting, direct bone-to-implant anchorage in man. Acta Orthop Scand. 1981;52(2):155-70. doi: 10.3109/17453678108991776.
citation: AlQahtani SM. A novel method of assessment of BMD using CBCT for implant placement: A retrospective study. Medicine (Baltimore). 2023 Jul 7;102(27):e34203. doi: 10.1097/MD.0000000000034203.
citation: Araujo MG, Lindhe J. Ridge alterations following tooth extraction with and without flap elevation: an experimental study in the dog. Clin Oral Implants Res. 2009 Jun;20(6):545-9. doi: 10.1111/j.1600-0501.2008.01703.x.
citation: Atsumi M, Park SH, Wang HL. Methods used to assess implant stability: current status. Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):743-54.
citation: Bhola M, Neely AL, Kolhatkar S. Immediate implant placement: clinical decisions, advantages, and disadvantages. J Prosthodont. 2008 Oct;17(7):576-81. doi: 10.1111/j.1532-849X.2008.00359.x. Epub 2008 Aug 26.
citation: Mantena SR, Sivagami G, Gottumukkala SN. Evaluation of crestal bone loss and stability of immediate functional loading versus immediate non-functional loading of single-mandibular posterior implants: A pilot randomized controlled clinical trial. Dent Res J (Isfahan). 2014 Sep;11(5):585-91.