Treatment Outcome of Short Implant Assisted Mandibular Overdenture

July 25, 2021 updated by: Sara Zayed

Treatment Outcome of Short Implant Assisted Mandibular Overdenture in Combination With Low Level Laser Therapy

This study evaluates the use of short dental implants to support mandibular overdenture together with the use of laser therapy for treatment of patients with atrophic ridges. All participants will receive laser therapy; half of participants will receive two short implants and the other half will receive four short implants.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The conventional solution to complete edentulism is the use of complete removable dentures. One negative effect of edentulism is resorption of the edentulous ridge over time. Construction of a successful mandibular complete denture for patients with advanced mandibular ridge resorption is often difficult and on some occasions virtually impossible. It has been proved that when implants are placed, bone gets stimulated resulting in minimal bone loss. But anatomic limitations to implant placement have been observed in atrophic ridges, so short implants introduced as a recent alternative to aggressive surgical procedures proposed to compensate for tissue deficiency. Also, Low Level Laser Therapy (LLLT) has proven success in improving implant stability which is very crucial in short implants. Thus, the purpose of this study is to evaluate and compare the treatment outcome of mandibular overdenture assisted by two short implants versus that assisted by four short implants in combination with LLLT.

Study Type

Interventional

Enrollment (Actual)

12

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
      • Alexandria, Egypt
        • Faculty of Dentistry

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

43 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Completely edentulous patients.
  • Patients with mandibular resorbed edentulous ridge.
  • Medically fit patients with no systemic conditions.
  • Class I ridge relation.
  • Adequate zone of keratinized mucosa.

Exclusion Criteria:

  • Metabolic bone disease or unstable systemic condition.
  • Heavy smokers.
  • A history of radiotherapy in the head and neck region.
  • Physical or mental disability.
  • Temporomandibular and neuromuscular disorders.

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: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Two short implants and 2 minutes LLLT
Patients receiving 2 short dental implants assisted mandibular over-denture and Low level laser therapy (LLLT) for 2 minutes .
Combination product: Two short implants and 2 minutes LLLT
Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 2 minutes.
Active Comparator: Two short implants and 4 minutes LLLT
Patients receiving 2 short dental implants assisted mandibular over-denture and LLLT for 2 minutes .
Combination product: Two short implants and 4 minutes LLLT
Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 4 minutes.
Active Comparator: Four short implants and 2 minutes LLLT
Patients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 2 minutes .
Combination product: Four short implants and 2 minutes LLLT
Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 2 minutes.
Active Comparator: Four short implants and 4 minutes LLLT
Patients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 4 minutes .
Combination product: Four short implants and 4 minutes LLLT
Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 4 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of changes in implant stability (Implant Stability Quotient).
Time Frame: Baseline, 6 months &12 months.
Implant stability can be defined as the absence of clinical mobility. It will be assessed at the time of implant placement (baseline) ,then six months and twelve months later, by the resonance frequency analysis using Osstel devise which measure implant oscillation frequency on the bone;Implant Stability Quotient (ISQ) .
Baseline, 6 months &12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-implant marginal bone changes.
Time Frame: Baseline, 6 months &12 months.
Radiographic assessment of bone level changes around each implant will be performed to detect peri-implant crestal bone changes using standardised digital periapical x-ray. It will be assessed at the time of implant placement, six months and twelve months later.
Baseline, 6 months &12 months.
Assessment of changes in peri-implant probing depth .
Time Frame: Baseline, 6 months &12 months.
Peri-implant probing depth is the distance between the gingival margin and the most apically probeable portion, in millimetres. It will be measured at four sites of each implant (mesially, labially, distally, lingually) by using a graduated periodontal probe which will be held parallel to the long axis of the implant and introduced to the peri-implant sulcus till there is slight resistance. The mean record for each implant will be calculated. It will be evaluated at time of definitive prosthesis insertion then, six months and twelve months after implant placement.
Baseline, 6 months &12 months.
Assessment of changes in modified gingival index
Time Frame: Baseline, 6 months &12 months.
To qualify the degree of peri-implant inflammation, the modified gingival index will be used. It will be measured at four sites around each implant (mesially, labially, distally, lingually) and the mean record for each implant will be calculated. It will be evaluated at time of definitive prosthesis insertion, then six months and twelve months after implant placement.
Baseline, 6 months &12 months.

Collaborators and Investigators

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

Sponsor

Sara Zayed

Investigators

  • Study Director: Sara Zayed, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2018

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

May 28, 2018

First Posted (Actual)

May 30, 2018

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 25, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01032018

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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