Implantation in Posterior Maxilla in Cases With Insufficient Bone

Implant Site Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06468592
• Other study ID #: UDDS-OMFS-1-2024
• Status: Completed
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: June 28, 2023

Study information

• Verified date: June 2024
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 28, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Years to 73 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Loss in Jaw
• Implant Site Reaction

Intervention

Procedure:
• Tilted insertion of implants
Using osteotomes, implants are inserted and tilted from 30° to 45° into the palatal direction from the maxillary sinus.
• Straight insertion of implants
The implants are inserted in an axial direction into the maxillary sinus according to Summers' traditional technique.

Locations

Country	Name	City	State
Syrian Arab Republic	Orthodontics Department, Faculty of Dentistry, University of Aleppo	Aleppo

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (9)

Barnea E, Tal H, Nissan J, Tarrasch R, Peleg M, Kolerman R. The Use of Tilted Implant for Posterior Atrophic Maxilla. Clin Implant Dent Relat Res. 2016 Aug;18(4):788-800. doi: 10.1111/cid.12342. Epub 2015 Apr 8. — View Citation

Boyne PJ. Analysis of performance of root-form endosseous implants placed in the maxillary sinus. J Long Term Eff Med Implants. 1993;3(2):143-59. — View Citation

Bruschi E, Manicone PF, De Angelis P, Papetti L, Pastorino R, D'Addona A. Comparison of Marginal Bone Loss Around Axial and Tilted Implants: A Retrospective CBCT Analysis of Up to 24 Months. Int J Periodontics Restorative Dent. 2019 Sep/Oct;39(5):675-684. doi: 10.11607/prd.4110. — View Citation

Del Fabbro M, Ceresoli V. The fate of marginal bone around axial vs. tilted implants: a systematic review. Eur J Oral Implantol. 2014 Summer;7 Suppl 2:S171-89. — View Citation

Malo P, de Araujo Nobre M. Partial rehabilitation of the posterior edentulous maxilla using axial and tilted implants in immediate function to avoid bone grafting. Compend Contin Educ Dent. 2011 Nov-Dec;32(9):E136-45. — View Citation

Penarrocha-Oltra D, Candel-Marti E, Ata-Ali J, Penarrocha-Diago M. Rehabilitation of the atrophic maxilla with tilted implants: review of the literature. J Oral Implantol. 2013 Oct;39(5):625-32. doi: 10.1563/AAID-JOI-D-11-00068. Epub 2011 Nov 28. — View Citation

Summers RB. The osteotome technique: Part 2--The ridge expansion osteotomy (REO) procedure. Compendium. 1994 Apr;15(4):422, 424, 426, passim; quiz 436. — View Citation

Summers RB. The osteotome technique: Part 3--Less invasive methods of elevating the sinus floor. Compendium. 1994 Jun;15(6):698, 700, 702-4 passim; quiz 710. — View Citation

Summers RB. The osteotome technique: Part 4--Future site development. Compend Contin Educ Dent. 1995 Nov;16(11):1090, 1092 passim; 1094-1096, 1098, quiz 1099. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The initial implant stability	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.	one time assessment at five minutes following the completion of inserting implants.