Implantation in Posterior Maxilla in Cases With Insufficient Bone

NCT06468592 | Completed DMC

• 1 other identifier: UDDS-OMFS-1-2024
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Loss in Jaw; Implant Site Reaction

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Tilted implants

EXPERIMENTAL

The tilted implants are inserted palatally into the maxillary sinus

Procedure: Tilted insertion of implants

Straight implants

ACTIVE COMPARATOR

The implants inserted into the maxillary sinus in an axial direction

Procedure: Straight insertion of implants

Interventions

Tilted insertion of implants PROCEDURE

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

Tilted implants

Straight insertion of implants PROCEDURE

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

Straight implants

Eligibility Criteria

• Age: 32 Years - 73 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Orthodontics Department, Faculty of Dentistry, University of Aleppo

Aleppo, Syria

Location

Related Publications (9)

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

  PMID: 8055514 BACKGROUND

• 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.

  PMID: 7994726 BACKGROUND

• 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.

  PMID: 8598008 BACKGROUND

• 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.

  PMID: 10146541 BACKGROUND

• 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.

  PMID: 24977252 BACKGROUND

• 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.

  PMID: 25853626 BACKGROUND

• 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.

  PMID: 23627307 BACKGROUND

• 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.

  PMID: 22121829 BACKGROUND

• 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.

  PMID: 31449578 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: June 21, 2024
• Study Start: March 2, 2022
• Primary Completion: January 15, 2023
• Study Completion: June 28, 2023
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)