Dental Implant Approach for Crestal Sinus Elevation; A Novel Technique.

Dental Implant Approach for Crestal Sinus Elevation; A Novel Technique. Case Series Study

Vertical bone height reduction after extraction in the posterior maxilla is inevitable and complicates the treatment plan. Crestal sinus elevation, using implants and different grafting procedures are considered some of the proposed treatment protocols. Ever since the introduction of implant dentistry and implant placement in the posterior maxilla has been a dilemma. The choice of the type of bone, anatomical landmarks and reduced remaining bone height are all obstacles faced when placing implants in this area. Vertical bone height reduction occurs post extraction of the maxillary molars and premolars by maxillary sinus pneumatization. Many protocols were suggested to overcome this phenomenon; placing short implants, 2nd premolar occlusion and finally maxillary sinus elevation.

A recent systematic review evaluated osteotomes mediated sinus floor elevation with or without grafting material. It concluded a high long term survival rate in both procedures, however only one comparative study was used in the analysis that involved 12 participants only. Another systematic review assessed the survival of implants placed with lateral versus crestal sinus approach in 4-8 mm ridge height. It concluded that the ability of the less invasive crestal sinus approach to replace one-stage lateral approach, however, only one randomized control trial was presented that involved 4o patients, and were followed-up for 5 years. This emphasizes the gap of knowledge in literature with high quality evidence concerning these approaches.

The purpose of the present study is to evaluate the radiographic vertical gain in bone height as well as the implant stability after implant placement without the use of bone grafts in posterior maxilla following sinus elevation using the crestal implant approach technique.

Study Overview

• Status: Completed
• Conditions: Dental Implant; Maxillary Sinus; Maxillary Sinus Lift; Maxillary Sinus Elevation
• Intervention / Treatment: Procedure: Dental Implant Approach for Crestal Sinus Elevation

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11728
    • International Dental Continuing Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Eligibility criteria:

Inclusion criteria:

1. Patients who have at least one missing posterior maxillary tooth with sound adjacent teeth.
2. Adults above the age of 18.
3. Residual Bone height from 5mm to 7mm under the maxillary sinus assessed in CBCT.
4. Mandibular posterior teeth opposing the tooth to be replaced for occlusion.
5. Good oral hygiene.
6. Patient accepts to provide an informed consent.

Exclusion criteria:

1. Smokers.
2. Pregnant and lactating females.
3. Medically compromised patients.
4. Patients with active infection related at the site of implant/bone graft placement.
5. Patients with untreated active periodontal diseases.
6. Patients with parafunctional habits.
7. Acute or chronic sinusitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dental Implant Approach for Crestal Sinus Elevation	Procedure: Dental Implant Approach for Crestal Sinus Elevation; Crestal Sinus Elevation by elevating the sinus membrane with a blunt ended dental implant approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intrasinus bone formation around implant	CBCT mm	1 year
Primary stability	torque measure	1 day
Surgical complications	Clinical assessment (Yes/No)	1 year
Implant Survival	Clinical assessment (Yes/No)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prosthetic complications	Clinical assessment (Yes/No)	1 year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IDCE.N4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No