Effectiveness in Limiting the Need to Elevate the Maxillary Sinus

NCT03357705 | Completed

• 1 other identifier: SO-GHI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to evaluate the effectiveness of different alveolar preservation procedures performed at the time of extraction of the first or second upper molar in avoiding a maxillary sinus elevation or at least limiting the size, to allow the insertion of dental implants. The residual bone height will be radiographically evaluated on the sinus sinus floor at the time of extraction and after 6 months by comparing the cases where alveolar preservation is performed using a nanocrystalline synthetic hydroxyapatite graft (group A) with cases where the procedure of alveolar preservation is performed using bovine collagen sponge (group B).

Conditions

Alveolar Bone Loss

Keywords

alveolar ridge preservation

Outcome Measures

Primary Outcomes (1)

• radiographic distance between crestal bone and implant platform

  necessity of sinus floor regeneration

  6 months after surgery

Study Arms (2)

synthetic

EXPERIMENTAL

alveolar ridge preservation with synthetic bone

Procedure: alveolar ridge preservation with synthetic bone

collagen

ACTIVE COMPARATOR

alveolar ridge preservation with bovine collagen

Procedure: alveolar ridge preservation with bovine collagen

Interventions

alveolar ridge preservation with synthetic bone PROCEDURE

after tooth extraction

Also known as: Ghimas

synthetic

alveolar ridge preservation with bovine collagen PROCEDURE

after tooth extraction

Also known as: Septodont

collagen

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• indication for extraction of the first or second upper molar, based on a thorough diagnosis and treatment plan;
• "three-rooted" anatomy of the first or second upper molar to be extracted so that it can have an inter-radicular septum that allows a precise measurement of the height of the bone ridge from the septum itself and from the walls of the 3 alveoli to the floor of the maxillary sinus;
• Extraction of intercalate molar or last arch element;

You may not qualify if:

• Anatomy of the molar with unique root or fused roots
• contextual extraction of the molar and one or more contiguous elements
• apical lesions with a diameter of\> 3 mm or cystic lesions with respect to the element to be extracted
• root fracture which has produced resorption or bone fenestration
• \) acute myocardial infarction in the last six months; 2) uncontrolled clotting disorders; 3) uncontrolled diabetes (HBA1c\> 7.5%); 4) radiotherapy in the head / neck district for the last 24 months; 5) immunocompromise (eg HIV infection or chemotherapy over the last 3 years); 6) treatment in progress or with bisphosphonates via e.v .; 7) autoimmune diseases in chronic therapy with methotrexate or other immunosuppressive drugs; 8) allergy to bovine collagen; 9) psychological or psychiatric problems; 10) abuse of alcohol or drug use; 11) uncontrolled periodontal disease;

Sponsors & Collaborators

• International Piezosurgery Academy: lead

Study Sites (1)

Piezosurgery Academy

Parma, 43100, Italy

Location

Related Publications (2)

• Carlsson GE, Bergman B, Hedegard B. Changes in contour of the maxillary alveolar process under immediate dentures. A longitudinal clinical and x-ray cephalometric study covering 5 years. Acta Odontol Scand. 1967 Jun;25(1):45-75. doi: 10.3109/00016356709072522. No abstract available.

  PMID: 5233859 BACKGROUND

• Sharan A, Madjar D. Maxillary sinus pneumatization following extractions: a radiographic study. Int J Oral Maxillofac Implants. 2008 Jan-Feb;23(1):48-56.

  PMID: 18416412 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Septodont

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Claudio Stacchi, Dr

  Piezosurgery Academy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of the International Piezosurgery Academy

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: November 30, 2017
• Study Start: October 31, 2017
• Primary Completion: October 31, 2018
• Study Completion: December 28, 2018
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)