Minimally Invasive Ridge Augmentation

Alveolar Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190576
• Other study ID #: 02_D012_80831
• Status: Completed
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2019
• Source: Krishnadevaraya College of Dental Sciences & Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Bone Density Increased

Intervention

Device:
• Low Level Laser Therapy
Hydroxyapatite bone graft with collagen

Locations

Country	Name	City	State
India	Krishnadevaraya college of dental sciences	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Krishnadevaraya College of Dental Sciences & Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gain in Alveolar ridge width in millimeters	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	6 months
Secondary	Change in Bone density in Hounsefield's units	Change in Bone density in Hounsefield units will be measured using Cone Beam Computed Tomography (CBCT) at baseline and six months	6 months
Secondary	Patient related outcomes of the surgical procedure in relation to 1) pain 2) discomfort and 3) swelling	Patient related outcomes during and after the procedure will be recorded	one week