Bone Height Gain Following Transcrestal Sinus Floor Elevation Using Piezoelectric Surgery Versus The Conventional Osteotome Technique

NCT03944811 | Completed

• 1 other identifier: 29011
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Missing teeth usually result in functional and cosmetic deficits. Traditionally, they have been restored with dentures or fixed bridges. However, dental implants represent an excellent alternative which rely on the maintenance of a direct structural and functional connection between living bone and implant surface, which is termed osseointergration. When sufficient bone is available in maxilla, implant rehabilitation has shown high success rates of 84-92 %. Atrophy of the alveolar crest and pneumatization of the maxillary sinus limits the quality and quantity of residual bone, therefore complicating the placement of implants in the posterior maxillary area.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• Amount of bone height gain

  6 months

Study Arms (2)

Transcrestal sinus floor elevation using Summers technique

ACTIVE COMPARATOR

Procedure: Summers technique

Transcrestal sinus floor elevation using piezoelectric surgery

EXPERIMENTAL

Procedure: piezoelectric device

Interventions

piezoelectric device PROCEDURE

crestal approach will be used to augment the maxillary sinus with simultaneous implant placement

Transcrestal sinus floor elevation using piezoelectric surgery

Summers technique PROCEDURE

Summers technique

Transcrestal sinus floor elevation using Summers technique

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients having one missing upper posterior tooth residual bone height beneath maxillary sinus from 5-8 mm.
• A minimum of 6 mm residual bone width at site of implant placement.
• The recipient site of the implant should be free from any pathological conditions.
• No diagnosed bone disease or medication known to affect bone metabolism.
• Patients who are cooperative, motivated and hygiene conscious.
• Patients having adequate inter-occlusal space of 8-10 mm.

You may not qualify if:

• Systemic conditions/diseases that contraindicate surgery.
• Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
• Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
• Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
• Patients that have any pathology in the maxillary sinuses.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Hassan El Barbary

Cairo, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 10, 2019
• Study Start: September 1, 2019
• Primary Completion: January 22, 2021
• Study Completion: April 1, 2021
• Last Updated: November 5, 2021

Record last verified: 2021-10

Locations

EG (1)