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OpenTrials
Completed

NCT Number: NCT06468592

Implantation in Posterior Maxilla in Cases With Insufficient Bone

Dental implant procedures are performed on two groups of individuals who share the common characteristic of insufficient bone for traditional implantation.

The first group lacks a palatal process, while the second group has a palatal process. Then, compare the initial primary stability of implants in the maxillary bone-type (D4) that were inserted tilted in the palatal process of the maxilla, palatally from the maxillary sinus, with implants inserted axially into the maxillary sinus by using a manual torque wrench.

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Key information

Age range

32 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthodontics Department, Faculty of Dentistry, University of Aleppo

Aleppo, Syria

About this study

Increasing the initial primary stability intensity value increases the success rate of implants in general and also allows immediate or early loading procedures to begin. In addition, to avoid complications resulting from inserting implants into the compromised maxillary sinus according to the Summers method. The most important of these is perforation of the mucous membrane lining the maxillary sinus and the possibility of its application in pathological cases of the maxillary sinus, such as chronic maxillary sinusitis and the presence of mucous retention cysts, in which intervention according to the usual Summers method is not indicated.

Despite the previous advantages obtained by this method, there are some disadvantages to the technique of tilting the implants in the palatal direction from the maxillary sinus, which are the limitation of its application to cases with a palatal process of the maxilla in the upper jawbone, which requires performing a three-dimensional radiograph. It was observed in this study and after studying the cross-sections that sufficient thickness for this process was less likely present than in cases of its absence. In addition, prosthetic procedures are generally difficult in tilted implants compared to axial implants.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

for both groups:

  • Patients must have inadequate bone density in the posterior region of the upper jaw.
  • Patients should maintain good oral hygiene.
  • The surgical site must be free from infection.
  • There should be no contraindications for oral surgery.

For the first group:

  • Patients in the first group must have a palatal process of the maxillary bone determined by radiographic examination.

Exclusion criteria

  • Patients with adequate bone volume to receive an implant.
  • Patients with systemic diseases that impair metabolism or healing at the surgical site.
  • Patients with contraindications for surgery, including cardiovascular disorders, blood clotting disorders, anticoagulant use, or uncontrolled diabetes.
  • Patients receiving medications that affect bone metabolism, such as corticosteroids, oral contraceptives, hormonal treatments, or those undergoing chemical or radiological therapies.

Treatment and study plan

Tilted insertion of implants

Procedure

Using osteotomes, implants are inserted and tilted from 30° to 45° into the palatal direction from the maxillary sinus.

Straight insertion of implants

Procedure

The implants are inserted in an axial direction into the maxillary sinus according to Summers' traditional technique.

Primary outcomes

  1. The initial implant stability

    Time frame: one time assessment at five minutes following the completion of inserting implants.

    Primary stability was recorded for all implants in both groups, estimated by Newton/cm (N/cm), using a manual torque wrench.

    This manual measure consists of a fixed arm installed above the implants and a moving arm moving away from the fixed arm in a clockwise direction, graduating from 5-45 Newtons. When the moving arm stops, the distance between it and the fixed arm expresses the first degree of the initial primary stability.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Implantation in the Palatal Process of the Maxilla as a Modification of the Osteotome Sinus Floor Elevation (Summers Technique)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 21, 2024
Registry last updated
Jun 21, 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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