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Minimally Invasive Ridge Augmentation

NCT ID: NCT04190576

Last Updated: 2019-12-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-10

Study Completion Date

2019-11-30

Brief Summary

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The present study is a human, prospective, randomised controlled clinical trial conducted to explore the outcome of a minimally invasive ridge augmentation technique with and without low level laser therapy. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Detailed Description

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Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients.

All the patients were treated with subperiosteal minimally invasive aesthetic ridge augmentation technique. the test group of ten were given low level laser therapy as an adjunct. The clinical and radiographic parameters were recorded at baseline and six months postoperatively.

Conditions

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Alveolar Bone Loss Bone Density Increased

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups were made one test and control. The control group were treated with MINIMALLY INVASIVE RIDGE AUGMENTATION technique alone and the test group were treated with adjunctive low-level laser therapy for bone regeneration.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Minimally invasive ridge augmentation with LLLT

Subperiosteal minimally invasive aesthetic ridge augmentation with G- Bone (Bone Graft) and low-level laser therapy

Group Type EXPERIMENTAL

Low Level Laser Therapy

Intervention Type DEVICE

Hydroxyapatite bone graft with collagen

Minimally invasive ridge augmentation

Subperiosteal minimally invasive aesthetic ridge augmentation with G- Bone (Bone Graft) alone

Group Type ACTIVE_COMPARATOR

Low Level Laser Therapy

Intervention Type DEVICE

Hydroxyapatite bone graft with collagen

Interventions

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Low Level Laser Therapy

Hydroxyapatite bone graft with collagen

Intervention Type DEVICE

Other Intervention Names

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G- Bone (Bone Graft)

Eligibility Criteria

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Inclusion Criteria

* Single or multiple edentulous sites with Seibert's class 1 defects corresponding to colognes 1 and 2
* ASA 1 and 2
* Patients with an esthetic concern
* Good oral hygiene

Exclusion Criteria

* Seibert's class 2 defects
* ASA 3 and 4
* Osteoporosis
* uncontrolled diabetes
* immunosuppression
* radiation therapy and bisphosphonate therapy
* Gingival thickness less than 2 mm
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Krishnadevaraya College of Dental Sciences & Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Prabhuji MLV

PROFFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Krishnadevaraya college of dental sciences

Bangalore, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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02_D012_80831

Identifier Type: -

Identifier Source: org_study_id