Clinical Trials Directory

Trials / Completed

CompletedNCT05843825

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
18 (actual)
Sponsor
Mansoura University · Academic / Other
Sex
Male
Age
50 Years – 60 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESurgical placement of dental implantsThree dental implants were placed (one anterior in midline area and two posterior at first molar area).
DEVICEOverdenture supported by locator attachment systemImplants 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

Timeline

Start date
2021-01-20
Primary completion
2022-01-23
Completion
2023-01-21
First posted
2023-05-06
Last updated
2023-05-06

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05843825. Inclusion in this directory is not an endorsement.