Clinical trial NCT05735613: Efficacy of Different Techniques of Crestal Sinus Lifting
Official title: The Efficacy of Different Techniques of Crestal Sinus Lifting to Place Dental Implant Into Prosterior Maxilla of Deficient Height: Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Sinus Augmentation
Keywords: deficient posterior maxilla
crestal sinus lift
dental implant
bone density
bone graft
maxillary sinus augmentation
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients divided into 3 groups:

Group 1:7patients treated by traditional closed sinus lift (osteotome) with bone grafting (xenograft) and implant placement.

Group 2:7patients treated by densah drills(Versah, Jackson, MI, USA) sinus lift with bone grafting (xenograft) and implant placement.

Group 3:7patients treated by piezoelectric (Piezotome; Satelec) crestal sinus lift with bone grafting (xenograft) and implant placement.
Primary purpose: TREATMENT

Brief summary: Twenty one patients with deficient posterior maxilla and alveolar bone height ≤ 5mm were included.Those patients randomly divided into 3 equal groups:

1. Group 1: 7 patients treated by osteotome closed sinus lift with bone grafting (xenograft) and implant placement.
2. Group 2: 7 patients treated by densah burs(Versah, Jackson, MI, USA) sinus lift with bone grafting (xenograft) and implant placement.
3. Group 3: 7 patients treated by piezoelectric (Piezotome; Satelec) crestal sinus lift with bone grafting (xenograft) and implant placement.

Detailed description: Patients have been asked asked to use 0.12% chlorhexidine digluconate rinse, and Povidone iodine solution will be used to perform extraoral antisepsis. After administration of local anesthesia at the implant site, a full thickness flap was elevated to expose the crest of alveolar ridge. A pilot drill will be used to start the osteotomy preparation, which should be ended 1mm short of sinus floor.

In group 1; (closed sinus lifting with Osteotome): The drills can be sequentially used to widen the osteotomy site to the same level (1 mm short of the sinus floor), an osteotome of diameter a little less than the planned implant body, will be inserted in the prepared osteotomy site and gently tapped to reach the same level, the osteotome will be tapped gently to fracture up the sinus floor.

In group 2; (closed sinus lifting with densah drills): Change the drill motor to reverse-densifying Mode (counterclockwise drill speed 800-1500 rpm with copious irrigation), Begin with the densah bur (2.5mm) until 1 mm short of the sinus floor, use the next wider Densah Bur (3.0mm) in the same mode and advance it into the previously created osteotomy with modulating pressure and a pumping motion. When feeling the haptic feedback of the drill reaching the dense sinus floor, modulate pressure with a gentle pumping motion to advance past the sinus floor in 1 mm increments, the next wider densah drills advance in the osteotomy.

In group 3: The initial osteotomy will be performed with a 2-mm twist drill to remove the cortical bone, then the intralift tips (Intralift; TKW1, TKW2, TKW3, TKW4, TKW5; Satelec). TKW1 to TKW4 tips have diameters of 1.35 mm, 2.1 mm, 2.35 mm, and 2.8 mm and will be used to gradually widen the access canal to the Schneider membrane, gentle pressure will be applied on the tips to deepen the pathway, and a sterile spray (80 mL/min) cooling the tips to avoid heat injury. The TKW5 tip will be then inserted into the access canal, and the ultrasonic activation for 5 seconds with internal irrigation of 40 mL/min and repeated at 50 mL/min and then 60 mL/min. The sinus membrane will be pushed upward by the hydraulic pressure, the floating of the sinus membrane will be evaluated, and then the TKW4 (Ø 2.8 mm) will be used again to widen the access canal to the sinus membrane before plugging the bone graft.

For all groups: Clinical check for membrane still intact, blocking the patient's nostrils and asking the patient to blow through his or her nose. Xenograft was added as the grafting material and pushed to the sinus through the osteotomy site until the desired height of sinus elevation will be gained, the implant fixture will be inserted. Smart peg will be placed on implant and Ostell will be used to record ISQ. Cover screw will be placed on implant and flab will be sutured. Sutures were removed after 10 days.

Eligibility criteria: Inclusion Criteria:

1. Young and adult patients of both sexes.
2. Patients exhibit class C residual bone height according to ABC sinus augmentation classification.(18)
3. The edentulous ridges are covered with mucoperiosteum free from signs of inflammation, ulceration or scar tissue.
4. Remaining natural teeth have good periodontal tissue support.
5. Occlusion showing sufficient inter-arch and intra-arch spaces for future prosthesis.

Exclusion Criteria:

1. Patients with systemic conditions that could influence the outcome of the therapy as: Pregnancy and Heavy smokers
2. Patients with systemic disease that may affect bone quality.
3. Uncooperative patients
4. Patients with active periodontal disease.
5. Patients with neglected oral hygiene.
6. Patients with limited mouth opening and unfavorable intermaxillary arch space.
7. Patients with maxillary sinus disease or previous sinus surgery.

Primary outcomes:
measure: dental implant stability
timeFrame: 6 months
measure: maxillary sinus augmentation
timeFrame: 6 months
Secondary outcomes:
measure: bone density
timeFrame: 6 months
measure: crestal bone loss
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The Faculty of Dentistry- AL-AZHAR University
Study officials:
affiliation: Al-Azhar University
name: Ahmed H. Hashem, Ass.Leturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vercellotti T, De Paoli S, Nevins M. The piezoelectric bony window osteotomy and sinus membrane elevation: introduction of a new technique for simplification of the sinus augmentation procedure. Int J Periodontics Restorative Dent. 2001 Dec;21(6):561-7.
citation: Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
citation: Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.