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Completed

NCT Number: NCT04190576

Minimally Invasive Ridge Augmentation

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.

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Key information

Conditions

Alveolar Bone Loss Bone Density Increased Bone Diseases Bone Diseases, Developmental Bone Resorption Mouth Diseases Musculoskeletal Diseases Osteochondrodysplasias Osteosclerosis Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Level Laser Therapy

Device

Hydroxyapatite bone graft with collagen

Other names: G- Bone (Bone Graft)

Primary outcomes

  1. Gain in Alveolar ridge width in millimeters

    Time frame: 6 months

    gain in alveolar ridge width at the agumented site in millimeters will be measured using Cone Beam Computed Tomography (CBCT) at baseline and six months

Secondary outcomes

  1. Change in Bone density in Hounsefield's units

    Time frame: 6 months

    Change in Bone density in Hounsefield units will be measured using Cone Beam Computed Tomography (CBCT) at baseline and six months

  2. Patient related outcomes of the surgical procedure in relation to 1) pain 2) discomfort and 3) swelling

    Time frame: one week

    Patient related outcomes during and after the procedure will be recorded

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study title

Subperiosteal Minimally Invasive Aesthetic Ridge Augmentation Technique With and Without Low Level Laser Therapy: A Comparative Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 9, 2019
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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