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

NCT05777239 | Completed

• 1 other identifier: IDCE.N4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Maxillary Sinus; Dental Implant; Maxillary Sinus Lift; Maxillary Sinus Elevation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• prosthetic complications

  1 year

Study Arms (1)

Dental Implant Approach for Crestal Sinus Elevation

EXPERIMENTAL

Procedure: Dental Implant Approach for Crestal Sinus Elevation

Interventions

Dental Implant Approach for Crestal Sinus Elevation PROCEDURE

Crestal Sinus Elevation by elevating the sinus membrane with a blunt ended dental implant approach

Dental Implant Approach for Crestal Sinus Elevation

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

International Dental Continuing Education

Cairo, 11728, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in the department of Oral Medicine & Periodontology

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 21, 2023
• Study Start: January 1, 2020
• Primary Completion: November 15, 2022
• Study Completion: February 15, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

EG (1)