NCT07840339

Brief Summary

The aim of this clinical study is to evaluate the accuracy of placing pterygoid implants using custom-made surgical guides in patients with atrophied posterior maxilla. The study focuses on measuring how closely the actual implant position matches the virtual preoperative plan in terms of angle and distance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

12 months

First QC Date

September 18, 2026

Last Update Submit

September 25, 2026

Conditions

Edentulous Maxilla, Atrophic

Keywords

Bone support vs mucosa supportPterygoid implantAccuracy of the surgical guideComputer-Aided Design

Outcome Measures

Primary Outcomes (1)

  • Accuracy of custom-made surgical guide

    Evaluation of the deviation between the virtual preoperative plan and the actual postoperative implant position. This includes angular (measured in angle degrees) and linear deviation (measured in mm).

    Immediately postoperative

Study Arms (1)

Guided Pterygoid Implant

EXPERIMENTAL

Patients with atrophic posterior maxilla receiving pterygoid implants using a custom-made digital surgical guide to evaluate placement accuracy.

Device: 3D Printed Digital Surgical Guide

Interventions

3D Printed Digital Surgical GuideDEVICE

A custom-made surgical template designed using technology based on the patient's CBCT and intraoral scans. It is used to guide the surgical drills and the placement of pterygoid implants according to a pre-planned virtual position to ensure accuracy

Guided Pterygoid Implant

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The age of the patients is between 20 and 60 years.
  • Partially and completely maxillary edentulous patients whose sinus pneumatization and refuse other treatment options.
  • Bone height related to the sinus is less than 5 mm.

You may not qualify if:

  • Soft and hard tissue pathology at the operation site
  • Patients with uncontrolled systemic disease
  • Prior radiation therapy
  • Previous chemotherapy and/or antiresorptive agents
  • Heavy smoking (e.g., two packs per day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

(Faculty of Dentistry - Tanta University

Tanta, Gharbia Governorate, 35111, Egypt

Location

MeSH Terms

Conditions

Atrophic Maxilla

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesMaxillary DiseasesJaw DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 25, 2026

Study Start

August 22, 2024

Primary Completion

August 8, 2025

Study Completion

April 10, 2026

Last Updated

September 29, 2026

Record last verified: 2026-09

Locations

EG(1)