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Treatment Outcome of Short Implant Assisted Mandibular Overdenture

Primary Purpose

Atrophy of Edentulous Mandibular Alveolar Ridge

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Two short implants and 2 minutes LLLT
Two short implants and 4 minutes LLLT
Four short implants and 2 minutes LLLT
Four short implants and 4 minutes LLLT
Sponsored by
Sara Zayed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophy of Edentulous Mandibular Alveolar Ridge

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Two short implants and 2 minutes LLLT

Two short implants and 4 minutes LLLT

Four short implants and 2 minutes LLLT

Four short implants and 4 minutes LLLT

Arm Description

Patients receiving 2 short dental implants assisted mandibular over-denture and Low level laser therapy (LLLT) for 2 minutes .

Patients receiving 2 short dental implants assisted mandibular over-denture and LLLT for 2 minutes .

Patients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 2 minutes .

Patients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 4 minutes .

Outcomes

Primary Outcome Measures

Assessment of changes in implant stability (Implant Stability Quotient).
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) .

Secondary Outcome Measures

Peri-implant marginal bone changes.
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.
Assessment of changes in peri-implant probing depth .
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.
Assessment of changes in modified gingival index
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.

Full Information

First Posted
May 2, 2018
Last Updated
July 25, 2021
Sponsor
Sara Zayed
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1. Study Identification

Unique Protocol Identification Number
NCT03540316
Brief Title
Treatment Outcome of Short Implant Assisted Mandibular Overdenture
Official Title
Treatment Outcome of Short Implant Assisted Mandibular Overdenture in Combination With Low Level Laser Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sara Zayed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy of Edentulous Mandibular Alveolar Ridge

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Two short implants and 2 minutes LLLT
Arm Type
Active Comparator
Arm Description
Patients receiving 2 short dental implants assisted mandibular over-denture and Low level laser therapy (LLLT) for 2 minutes .
Arm Title
Two short implants and 4 minutes LLLT
Arm Type
Active Comparator
Arm Description
Patients receiving 2 short dental implants assisted mandibular over-denture and LLLT for 2 minutes .
Arm Title
Four short implants and 2 minutes LLLT
Arm Type
Active Comparator
Arm Description
Patients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 2 minutes .
Arm Title
Four short implants and 4 minutes LLLT
Arm Type
Active Comparator
Arm Description
Patients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 4 minutes .
Intervention Type
Combination Product
Intervention Name(s)
Two short implants and 2 minutes LLLT
Intervention Description
Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 2 minutes.
Intervention Type
Combination Product
Intervention Name(s)
Two short implants and 4 minutes LLLT
Intervention Description
Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 4 minutes.
Intervention Type
Combination Product
Intervention Name(s)
Four short implants and 2 minutes LLLT
Intervention Description
Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 2 minutes.
Intervention Type
Combination Product
Intervention Name(s)
Four short implants and 4 minutes LLLT
Intervention Description
Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 4 minutes.
Primary Outcome Measure Information:
Title
Assessment of changes in implant stability (Implant Stability Quotient).
Description
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) .
Time Frame
Baseline, 6 months &12 months.
Secondary Outcome Measure Information:
Title
Peri-implant marginal bone changes.
Description
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.
Time Frame
Baseline, 6 months &12 months.
Title
Assessment of changes in peri-implant probing depth .
Description
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.
Time Frame
Baseline, 6 months &12 months.
Title
Assessment of changes in modified gingival index
Description
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.
Time Frame
Baseline, 6 months &12 months.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Zayed
Organizational Affiliation
Alexandria University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of dentistry
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
19696851
Citation
Thomason JM, Feine J, Exley C, Moynihan P, Muller F, Naert I, Ellis JS, Barclay C, Butterworth C, Scott B, Lynch C, Stewardson D, Smith P, Welfare R, Hyde P, McAndrew R, Fenlon M, Barclay S, Barker D. Mandibular two implant-supported overdentures as the first choice standard of care for edentulous patients--the York Consensus Statement. Br Dent J. 2009 Aug 22;207(4):185-6. doi: 10.1038/sj.bdj.2009.728.
Results Reference
background
PubMed Identifier
28291859
Citation
Maniewicz S, Buser R, Duvernay E, Vazquez L, Loup A, Perneger TV, Schimmel M, Muller F. Short Dental Implants Retaining Two-Implant Mandibular Overdentures in Very Old, Dependent Patients: Radiologic and Clinical Observation Up to 5 Years. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):415-422. doi: 10.11607/jomi.5361.
Results Reference
background
PubMed Identifier
25958474
Citation
Mandic B, Lazic Z, Markovic A, Mandic B, Mandic M, Djinic A, Milicic B. Influence of postoperative low-level laser therapy on the osseointegration of self-tapping implants in the posterior maxilla: a 6-week split-mouth clinical study. Vojnosanit Pregl. 2015 Mar;72(3):233-40. doi: 10.2298/vsp131202075m.
Results Reference
background
PubMed Identifier
17362493
Citation
Malo P, de Araujo Nobre M, Rangert B. Short implants placed one-stage in maxillae and mandibles: a retrospective clinical study with 1 to 9 years of follow-up. Clin Implant Dent Relat Res. 2007 Mar;9(1):15-21. doi: 10.1111/j.1708-8208.2006.00027.x.
Results Reference
background
PubMed Identifier
36247059
Citation
Zayed SM, Noureldin MG. Rehabilitation of Atrophic Mandible with Ultrashort Implants Combined with Photobiomodulation Therapy: A Split-Mouth Design Study. Saudi J Med Med Sci. 2022 Sep-Dec;10(3):198-206. doi: 10.4103/sjmms.sjmms_635_21. Epub 2022 Aug 22.
Results Reference
derived

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Treatment Outcome of Short Implant Assisted Mandibular Overdenture

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