Clinical trial NCT05777239: Dental Implant Approach for Crestal Sinus Elevation; A Novel Technique.
Official title: Dental Implant Approach for Crestal Sinus Elevation; A Novel Technique. Case Series Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Sinus
Dental Implant
Maxillary Sinus Lift
Maxillary Sinus Elevation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Intrasinus bone formation around implant
timeFrame: 1 year
measure: Primary stability
timeFrame: 1 day
measure: Surgical complications
timeFrame: 1 year
measure: Implant Survival
timeFrame: 1 year
Secondary outcomes:
measure: prosthetic complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: International Dental Continuing Education
Study officials:
References: