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

Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05777239
• Other study ID #: IDCE.N4
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: February 15, 2023

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 15, 2023
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implant
• Maxillary Sinus
• Maxillary Sinus Lift

Intervention

Procedure:
• Dental Implant Approach for Crestal Sinus Elevation
Crestal Sinus Elevation by elevating the sinus membrane with a blunt ended dental implant approach

Locations

Country	Name	City	State
Egypt	International Dental Continuing Education	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrasinus bone formation around implant	CBCT mm	1 year
Primary	Primary stability	torque measure	1 day
Primary	Surgical complications	Clinical assessment (Yes/No)	1 year
Primary	Implant Survival	Clinical assessment (Yes/No)	1 year
Secondary	prosthetic complications	Clinical assessment (Yes/No)	1 year