Treatment Outcome of Short Implant Assisted Mandibular Overdenture

NCT ID: NCT03540316

Last Updated: 2021-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2024-01-31

Brief Summary

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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

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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.

Conditions

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Atrophy of Edentulous Mandibular Alveolar Ridge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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 .

Group Type ACTIVE_COMPARATOR

Two short implants and 2 minutes LLLT

Intervention Type COMBINATION_PRODUCT

Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 2 minutes.

Two short implants and 4 minutes LLLT

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

Group Type ACTIVE_COMPARATOR

Two short implants and 4 minutes LLLT

Intervention Type COMBINATION_PRODUCT

Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 4 minutes.

Four short implants and 2 minutes LLLT

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

Group Type ACTIVE_COMPARATOR

Four short implants and 2 minutes LLLT

Intervention Type COMBINATION_PRODUCT

Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 2 minutes.

Four short implants and 4 minutes LLLT

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

Group Type ACTIVE_COMPARATOR

Four short implants and 4 minutes LLLT

Intervention Type COMBINATION_PRODUCT

Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 4 minutes.

Interventions

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Two short implants and 2 minutes LLLT

Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 2 minutes.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sara Zayed

OTHER

Sponsor Role lead

Responsible Party

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Sara Zayed

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sara Zayed

Role: STUDY_DIRECTOR

Alexandria University

Locations

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Faculty of dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 19696851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28291859 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25958474 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17362493 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36247059 (View on PubMed)

Other Identifiers

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01032018

Identifier Type: -

Identifier Source: org_study_id

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