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Completed

NCT Number: NCT04521530

Immediate Functional Versus Non Functional Implant Loading in the Mandible

comparing immediate functionally loaded implants and immediate non functionally loaded implants in the posterior mandibular region on bases of bone density and bone loss evaluated by cone-beam computed tomography (CBCT).

Completed

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Key information

Conditions

Dental Implants Edentulous Alveolar Ridge

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

About this study

Patients are more demanding after the revolution in immediate implant dentistry which reduces implant procedure nowadays according to literature and research. In response to patients' demands not only implants are immediately placed but also immediately loaded within 72 hours reducing the time for prosthetic loading and also improving bone formation according to some studies. The debate in modern implant dentistry is whether to immediately load the implants in functional occlusion or non-functional occlusion and which will improve the osseointegration and reduce crestal bone loss.

Implants of the BioInfinity system were placed in 16 subjects divided into two groups.

Group (A): 8 patients with missing posterior mandibular teeth whom will be rehabilitated with immediate functionally loaded implants.

Group (B): 8 patients with missing posterior mandibular teeth in whom immediate non-functionally loaded implants were used.

The two groups were evaluated at baseline, immediately after implant placement and 4 months postoperative to evaluate crestal bone level and quantitative radiographic bone density using CBCT.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients aged (20-40) years old.
  • Missing Posterior tooth or teeth indicated for implant placement.
  • Residual alveolar ridge at least 10 mm high and at least 4 mm wide.

Exclusion criteria

  • Systemic diseases that will contraindicate the surgery.
  • Poor Oral Hygiene.
  • The patient refuses to undergo the surgery.
  • Parafunctional habits.

Treatment and study plan

immediate functional implant loading

Other

Patients will undergo implant placement and a minimum of 35 Ncm reading with the graded torque wrench. Temporary crowns in functional occlusion were cemented.

immediate non functional implant loading

Other

implant will be placed into the site following the manufacturer's protocol making sure to have a minimum of 35 Newton centimeter reading with the degraded torque wrench. Non-functional temporary crowns were cemented.

Primary outcomes

  1. Pain score

    Time frame: immediately Postoperatively

    Visual analogue scale consist of a scale of 10 0 means no pain 10 menas pain is as bad as it could possibly be

  2. Change in crestal bone loss

    Time frame: immediately Postoperatively and after 4 months

    CBCT was done immediately after implant placement and 4 months postoperatively to assess crestal bone loss

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

A Comparative Study Between Immediate Functional and Non-functional Loading of Dental Implants in the Posterior Alveolar Mandibular Region (a Randomized Clinical Trial)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 20, 2020
Registry last updated
Aug 20, 2020

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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