Immediate Versus Delayed Loading for Implants Retaining Mandibular Complete Overdenture

Bone Loss Clinical Trial

Official title:

Immediate Versus Delayed Loading for Immediately Inserted Implants Retaining Mandibular Complete Overdenture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05620797
• Other study ID #: implant_86_2018
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study will be to compare the amount of marginal bone height changes between immediate and delayed loading for immediately inserted implants used as abutments of mandibular overdenture.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient having two standing mandibular canines with compromised prognosis (which indicted for extraction, without any preapical lesions nor acute infection) and have an adequate labial bone thickness.

• Patient having opposing completely edenteolous maxilla.

• Patients having normal maxilla-mandibular relationship and sufficient inter arch distance was insured by through tentative jaw relation record.

• Patients with good oral hygiene.

• Enough bone volume for implants in the interforaminal region (adequate bone quality and quantity)

Exclusion Criteria:

• Mental disorder patients who are not capable of making a decision or narcotic drug addicts.

• Patients with Tempro-Mandibular Joint disorders

• Patients undergoing radiotherapy or chemotherapy

• Patients with systemic diseases affecting bone metabolism

• Uncooperative patients who have no understanding of the need of a regular follow-up.

• Patient with pathological defects in the areas of implant insertion.

• Vulnerable group as prisoners, mentally retarded patients.

Related Conditions & MeSH terms

• Bone Loss
• Dental Implant

Intervention

Other:
• Immediate loading of the implants
Patients of this group will be rehabilitated by implant-retained mandibular overdenture with immediate loading of the implants as opposed to conventional maxillary complete dentures.
• Delayed loading of the implant
Patients of this group will be rehabilitated by implant retained mandibular overdenture with delayed loading of the implants (after 3 months) opposed by conventional maxillary complete dentures

Locations

Country	Name	City	State
Egypt	Ain Shams Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bone loss	Every 3 months all patients were recalled for assessment of marginal bone loss. The assessment was done using digital periapical radiograph Ezsensor (Vatech intraoral radiographic sensor, Vatech, South Korea) and the technique of radiograph was paralleling technique using sensor holder (TROLLBYTE PLUS, TROLLDENTAL, UK) to ensure same position of cone through subsequent follow-up exposures	at 3 months, 6 months, 9 months, 12 months