Immediate Versus Delayed Loading for Implants Retaining Mandibular Complete Overdenture

NCT05620797 | Completed

• 1 other identifier: implant_86_2018
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Loss; Dental Implant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Immediate loading implants

EXPERIMENTAL

Other: Immediate loading of the implants

Delayed loading implants

ACTIVE COMPARATOR

Other: Delayed loading of the implant

Interventions

Immediate loading of the implants OTHER

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.

Immediate loading implants

Delayed loading of the implant OTHER

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

Delayed loading implants

Eligibility Criteria

• Age: 55 Years - 65 Years
• Gender Eligibility Details: Males only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Ain Shams Faculty of Dentistry

Cairo, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 17, 2022
• Study Start: March 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

EG (1)