Effect of Block-out Spacer to Pick up Locator Attachments to Retain Overdenture: Peri-implant and Alveolar Bone Changes

NCT05843825 | Completed

• 1 other identifier: M11071020
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to radiographically evaluate peri-implant and alveolar bone height changes of locator attachments used for three implant assisted mandibular complete overdenture using two different pick up protocols.

Conditions

Bone Loss

Keywords

Peri-implant; Alveolar bone

Outcome Measures

Primary Outcomes (1)

• Peri-implant bone height changes (bone loss)

  Evaluations of vertical and horizontal peri-implant bone loss in mm by digital periapical radiography.

  one year.

Secondary Outcomes (1)

• Residual alveolar bone height changes (bone loss)

  one year.

Study Arms (2)

(BOS-G) Block out spacer group

ACTIVE COMPARATOR

(BOS-G)(Control group) : Patients who would be delivered mandibular overdenture retained by three locator attachments picked up using block out spacer .

Procedure: Surgical placement of dental implants; Device: Overdenture supported by locator attachment system

(WBOS-G) Without block out spacer group

ACTIVE COMPARATOR

(WBOS-G) (Study group): Patients who would be delivered mandibular overdenture retained by three locator attachments picked up without using block out spacer .

Procedure: Surgical placement of dental implants; Device: Overdenture supported by locator attachment system

Interventions

Surgical placement of dental implants PROCEDURE

Three dental implants were placed (one anterior in midline area and two posterior at first molar area).

(BOS-G) Block out spacer group; (WBOS-G) Without block out spacer group

Overdenture supported by locator attachment system DEVICE

Implants were loaded after three months by using locator attachments. Control group:Iocator attachments picked up using block out spacer. Study group:Iocator attachments picked up without using block out spacer

(BOS-G) Block out spacer group; (WBOS-G) Without block out spacer group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good oral hygiene practiced by edentulous patients.
• Completely edentulous maxillary and mandibular arches (at least six months since last extraction) .
• Mandibular residual alveolar ridge mucosa was healthy, firmly attached, well keratinized, free from any ridge flabbiness and even compressible mucosa as detected by palpitation with the blunt end of the mirror .
• Mandibular residual alveolar ridge form was U-shaped with accepted bone width, height and density as assessed by cone beam computed tomography.
• Angle's class I maxillo-mandibular relationship.
• Sufficient restorative space vertically not less than (8.5mm) and horizontally not less than (9 mm) which were verified by tentative jaw relation record and mounting on the articulator .

You may not qualify if:

• Systemic diseases relating to the bone resorption(e.g. osteoporosis , uncontrolled diabetes, osteogenesis imperfecta…etc).
• Administrated drugs that interfere with bone quality (e.g. corticosteroids, thyroxin, levothyroxine... etc).
• Patients with absolute contraindication for surgical implantation (recent myocardial infarction, cerebrovascular accident, valvular prosthesis surgery, immunosuppression, bleeding issues….etc).
• General contraindication for surgical procedures such as patient with head and neck radiotherapy and hepatic patients.
• Patients with relative contraindication: history of para functional habits such as bruxism, clenching and bad habits such as smoking and alcoholism .
• Local contraindication for surgical implantation (close proximity to vital structure, pathological lesion, remaining root not indicated for removal , localized bone defects or poor bone quality (D4)).
• Allergic reactions to titanium or to local anesthesia

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Rahma El Hussany

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

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

Study Officials

• Rahma El Hussany, MD

  Mansoura University Faculty of Dentistry Prosthodontics Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The selected patients were stratified according to age, gender, years of mandibular edentulism, number of old non-satisfactory dentures. Patients were assigned to one of two groups using balanced randomization procedure to ensure comparability between groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients were randomly assigned into two equal groups . (BOS-G) Block out spacer group : patients who would be delivered mandibular implant overdenture retained by three locator attachments using block out spacer during pick up .(WBOS-G) Without block out spacer group : patients who would be delivered mandibular implant overdenture retained by three locator attachments without using block out spacer during pick up

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 6, 2023
• Study Start: January 20, 2021
• Primary Completion: January 23, 2022
• Study Completion: January 21, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)