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

May 2, 2023 updated by: Rahma elhussany mohammed, Mansoura University

Effect of Using Block-out Spacer During Picking up of Locator Attachments Used for Retaining 3 Implant Mandibular Complete Overdenture: Peri-implant and Alveolar Bone Height Changes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This clinical trial was done to evaluate the effect of using block-out spacer during picking up of locator attachments used for retaining 3 implant mandibular complete overdenture regarding peri-implant and alveolar bone height changes.

Eighteen egyptian completely edentulous male patients were chosen from the Outpatient Clinic of the Prosthodontics Department, Faculty of Dentistry, Mansoura University, Egypt.

Patients received three implants one anterior in midline area and two posterior at first molar area .

Patients free from any systemic diseases relating to the bone resorption, not taking any drugs that interfere with bone quality .Patients with absolute contraindication for surgical implantation, general contraindication , relative contraindication ,local contraindication for surgical implantation , allergic reactions to titanium or to local anesthesia were excluded.

The main question it aims to answer is whether to use block-out spacer during picking up of locator attachments used for retaining 3 implant mandibular complete overdenture or not.

  • Participants were given antibiotic prophylaxis (clavulanic acid with amoxicillin 1 gm twice/day) one hour prior to surgery and continued for 6-7 days postoperative .Also, 50 mg of non-steroid anti-inflammatory tablets and analgesic (Declophenac tab) were given twice daily for one week after surgery. In addition to, Antiseptic mouth wash (0.2% chlorohexidine) was started ten minutes before surgery and continued one week after surgery twice daily.
  • Patients were asked for radiographic evaluation immediately (T0) and 6 (T6) then 12 months (T12) after picking up of locator attachments.

Researcher compared between Block out spacer group (BOS-G) and Without block out spacer group (WBOS-G)which were randomly assigned into two equal groups to see if using block out spacer during picking up of locator attachments used for retaining 3 implant mandibular complete overdenture is more beneficial regarding peri-implant and alveolar bone height changes or not.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Rahma El Hussany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 .

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: (BOS-G) Block out spacer group
(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
Three dental implants were placed (one anterior in midline area and two posterior at first molar area).
Device: Overdenture supported by locator attachment system

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
Active Comparator: (WBOS-G) Without block out spacer group
(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
Three dental implants were placed (one anterior in midline area and two posterior at first molar area).
Device: Overdenture supported by locator attachment system

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-implant bone height changes (bone loss)
Time Frame: one year.
Evaluations of vertical and horizontal peri-implant bone loss in mm by digital periapical radiography.
one year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual alveolar bone height changes (bone loss)
Time Frame: one year.
Evaluations of vertical residual alveolar bone loss in mm by panoramic radiography.
one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Rahma El Hussany, MD, Mansoura university Faculty of Dentistry Prosthodontics Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Actual)

January 23, 2022

Study Completion (Actual)

January 21, 2023

Study Registration Dates

First Submitted

April 21, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Estimate)

May 4, 2023

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M11071020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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