Vertical Versus Inclined Implant to Retain Locator Maxillary Overdenture

NCT05843331 | Completed

• 1 other identifier: A26060722
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: evaluate the success rate, prosthetic maintenance , clinical and radiologic results of vertical implants with straight abutments versus inclined implants with angled abutments to retain locator maxillary overdentures. There were two groups : 1) The control group 2) The study group

Conditions

Implant Complication; Bone Loss

Keywords

maxillary overdentures; angled abutment; locator

Outcome Measures

Primary Outcomes (3)

• plaque index

  measure plaque around each implant using Mombelli indices

  12 months

• pocket depth

  dental probe used to measure the depth of formed pocket around each implant

  12 months

• implant stability

  stability of each implant measured using Osstell® device

  12 months

Secondary Outcomes (1)

• Radiographic outcome

  12 months

Study Arms (2)

posterior vertical implants

ACTIVE COMPARATOR

the anterior implants were inserted in the canine/lateral incisor area bilaterally to each other's following the contour of the alveolar bone of the premaxilla. The posterior implants were inserted vertically just anterior to the maxillary sinus (in the area of second premolars) .

Procedure: implants

posterior inclined implants

ACTIVE COMPARATOR

The anterior implants were inserted in the canine/lateral incisor area bilaterally to each other's and will be inclined 15o labially following the contour of the alveolar bone of the premaxilla. The posterior implants were inserted just anterior to the maxillary sinus (in the area of second premolars) and inclined 15o distally .

Procedure: implants

Interventions

implants PROCEDURE

Four implants in the maxilla with locator attachments

posterior inclined implants; posterior vertical implants

Eligibility Criteria

• Age: 58 Years - 68 Years
• Gender Eligibility Details: 6 males and 6 females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unable to wear the upper denture
• Radiographic diagnosis of bone loss

You may not qualify if:

• Neuromuscular diseases
• Insulin dependent diabetes

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, 35516, Egypt

Location

Related Publications (2)

• ELsyad MA, Emera RM, Ashmawy TM. Effect of Distal Implant Inclination on Dislodging Forces of Different Locator Attachments Used for Mandibular Overdentures: An In Vitro Study. J Prosthodont. 2019 Feb;28(2):e666-e674. doi: 10.1111/jopr.12710. Epub 2017 Nov 16.

  PMID: 29143403 BACKGROUND

• ELsyad MA, Abo Hatem OE, Shawky AF, Emera RMK. Effect of Different Degrees of Mesial Implant Inclination on the Retention and Stability of Two-Implant Mandibular Overdentures Retained with Stud Attachments: An In Vitro Study. Int J Oral Maxillofac Implants. 2018 March/April;33(2):259-268. doi: 10.11607/jomi.5791. Epub 2017 Oct 13.

  PMID: 29028850 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Marwa Aboelez, Phd

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Mostafa Elsyad, Phd

  Mansoura University

  STUDY CHAIR

Study Design

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

Model Details: Randomized controlled clinical trial study conducted on 12 participants with completely edentulous maxillary ridges. Patients were allocated into one of two treatment groups: 1) The control group ; included 6 patients (3 males and 3 females) who will receive 4 vertical implants with straight trans mucosal abutments retaining locator maxillary overdenture 2) The study group; include 6 participants (3 males and 3 females) who will receive 4 inclined implants with angled trans mucosal abutments for retaining locator maxillary overdenture. A new maxillary conventional dentures will be constructed with a bilateral balanced occlusal concept for all patients. Maxillary dentures were duplicated into heat cure acrylic resin dentures to be used as a radiographic template. Four implants were inserted in the maxilla . For both groups, locator abutments were screwed to the abutments .Clinical and radiographic evaluations were done.

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 6, 2023
• Study Start: January 15, 2022
• Primary Completion: March 25, 2023
• Study Completion: April 2, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)