Indirect Sinus Augmentation with and without the Addition of a Biomaterial: A Randomized Controlled Clinical Trial?

Phase 2

• Conditions: Endo- sinus bone gain post indiect sinus lift operation; Acemannan sponges; Bone formation; Bone substitute; Sinus augmentation

• Registration Number: TCTR20181217004
• Lead Sponsor: ational Research Council of Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-17
• Study Completion: 2019-08-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

The healthy person with missing upper first and second molar and the residual height bone from 6-8 mm.
Person who has sufficient bone in mesio-distal and bucco-lingual directions (at least 1 mm of periimplant bone around the implant).

Exclusion Criteria

Patients with compromised medical conditions, active acute or chronic sinusitis, head and neck radiotherapy, heavy alcohol consumption (binge drinking on ≥5 days in the past month), smoking more than 10 cigarettes per day, or taking bisphosphonates.
Allergy to anesthetics or herbal medicines

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endo-sinus bone gain Immediate, at 3- and 6-months post-operation Cone beam computed tomography (CBCT).

Secondary Outcome Measures

Name	Time	Method
Clinical signs 1 and 7 days Pain scale, swelling scale