Treatment Outcome of Short Implant Assisted Mandibular Overdenture
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 2, 2018
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedJuly 27, 2021
July 1, 2021
5.6 years
May 2, 2018
July 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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) .
Baseline, 6 months &12 months.
Secondary Outcomes (3)
Peri-implant marginal bone changes.
Baseline, 6 months &12 months.
Assessment of changes in peri-implant probing depth .
Baseline, 6 months &12 months.
Assessment of changes in modified gingival index
Baseline, 6 months &12 months.
Study Arms (4)
Two short implants and 2 minutes LLLT
ACTIVE COMPARATORPatients receiving 2 short dental implants assisted mandibular over-denture and Low level laser therapy (LLLT) for 2 minutes .
Two short implants and 4 minutes LLLT
ACTIVE COMPARATORPatients receiving 2 short dental implants assisted mandibular over-denture and LLLT for 2 minutes .
Four short implants and 2 minutes LLLT
ACTIVE COMPARATORPatients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 2 minutes .
Four short implants and 4 minutes LLLT
ACTIVE COMPARATORPatients receiving 4 short dental implants assisted mandibular over-denture and LLLT for 4 minutes .
Interventions
Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 2 minutes.
Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 4 minutes.
Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 2 minutes.
Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 4 minutes.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sara Zayedlead
Study Sites (1)
Faculty of dentistry
Alexandria, Egypt
Related Publications (5)
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.
PMID: 19696851BACKGROUNDManiewicz 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.
PMID: 28291859BACKGROUNDMandic 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.
PMID: 25958474BACKGROUNDMalo 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.
PMID: 17362493BACKGROUNDZayed 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.
PMID: 36247059DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sara Zayed
Alexandria University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
May 2, 2018
First Posted
May 30, 2018
Study Start
May 1, 2018
Primary Completion
December 1, 2023
Study Completion
January 1, 2024
Last Updated
July 27, 2021
Record last verified: 2021-07