Clinical trial NCT05495490: Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement
Official title: Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maxillary Sinus Floor Augmentation
Keywords: Osseodensification
Osteotome
Internal Sinus Lifting
Sticky Bone
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel single-blind masking randomized controlled clinical trial
Primary purpose: TREATMENT

Brief summary: The sinus lift technique through alveolar crest Osseodensification is conservative, minimally invasive, and minimally traumatic, utilizing hydropneumatic counterclockwise rotating instruments to lift the maxillary sinus floor without touching the Schneiderian membrane, thereby minimizing the risk of perforation. In contrast, the internal sinus lift technique utilizing osteotomes to raise the Schneiderian membrane eliminated hammering, making the technique more patient-friendly, with the placement of a graft biomaterial around the implant. The challenge in this technique was the availability of \> 5mm residual bone height preventing membrane perforation and low primary implant stability. Consequently, the investigator aims to compare the efficacy and clinical outcomes of Osseodensification and Osteotome internal sinus lifting after delayed implant placement by assessing bone gain and bone density around implants radiographically, the primary stability of the implants clinically, and patient satisfaction.

Detailed description: Twenty patients with maxillary posterior edentulous ridge will be randomly assigned to one of two equal groups: Osseodensification sinus lift using sticky bone as a graft material (Group 1) and Osteotome internal sinus lift using sticky bone as a graft material (Group 2). (Group 2). Using Cone Beam Computed Tomography (CBCT), the sinus anatomy and height and width of the residual ridge from the sinus floor to the alveolar crest of all patients will be evaluated prior to surgery. Each patient will then receive pre-surgical medication consisting of intravenous steroidal anti-inflammatory drug (dexamethasone sodium phosphate 4mg) one hour prior to the procedure and oral rinsing with 0.12 percent chlorhexidine for one minute. After surgery, patients will receive 14 days of twice-daily chlorhexidine rinses 0.12 percent for postoperative treatment. Patients allergic to penicillin are given 1 g amoxicillin twice daily for six days or 0.5 g azithromycin. Ibuprofen (400) should be administered three times daily unless medically contraindicated. After insertion, the primary stability of each implant will be evaluated using a torque wrench and an Osstell device. All patients will undergo immediate postoperative CBCTs to assess bone gain and bone density. Utilizing the Visual Analogue Scale, patients' pain will be evaluated (VAS). A health-related quality of life questionnaire will be used to evaluate the patients' perception of recovery in terms of pain, oral function, general activity, and other symptoms. Postoperatively, the operator's subjective satisfaction with Osseodensification and Osteotome sinus lift techniques will be evaluated using a second printed questionnaire.

Eligibility criteria: Inclusion Criteria:

* 1. Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months.

  2. Both sexes will be selected males and females.

  3. Adult patients aged between 18 and 40 years of age.

  4. Good general health (American Society of Anesthesiology Physical Status Ⅰ-Ⅱ).

  5. Initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT.

  6. No previous surgery or radiation treatment on the maxillary sinus.

Exclusion Criteria:

* 1. Smokers.

  2. Pregnant or lactating females.

  3. Psychiatric disorders.

  4. Uncontrolled systemic disease.

  5. Hematologic diseases and coagulation disorders.

  6. Chemotherapy or radiotherapy of the head and neck area, and immunocompromised status.

  7. Medical conditions affecting bone metabolism and ongoing treatment with bisphosphonates drugs or systemic steroids.

  8. Presence of acute or chronic sinus pathoses or sinus membrane perforation.

Primary outcomes:
measure: Radiographic Assessment of Change in the Vertical Bone Height (Bone Gain).
timeFrame: Pre-operative and Immediately post-operative.
measure: Radiographic Assessment of Change in the Bone Density.
timeFrame: Pre-operative and Immediately post-operative.
Secondary outcomes:
measure: Clinical Assessment of Primary Stability of the Implants ( Insertion Torque Value) Measured by a Torque Wrench.
timeFrame: During procedure.
measure: Clinical Assessment of Primary Stability of the Implants (Implant Stability Quotient ) Measured by an Osstell® Device.
timeFrame: During procedure.
measure: Patient's Post-Operative Pain Assessment
timeFrame: 1 week post-operative
measure: Patient's Satisfaction Assessment.
timeFrame: 1 week post-operative
measure: Operator's Satisfaction Assessment
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Dentistry- Assiut University
city: Cairo
country: Egypt
facility: Faculty of Dentistry- Ain Shams University
Study officials:
affiliation: Faculty of Dentistry- Ain Shams University
name: Hala A. Abuel- Ela, Professor
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry- Ain Shams University
name: Mohamed W. Bissar, Lecturer
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry- Ain Shams University
name: Omneya M. Elkadi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huwais S, Mazor Z, Ioannou AL, Gluckman H, Neiva R. A Multicenter Retrospective Clinical Study with Up-to-5-Year Follow-up Utilizing a Method that Enhances Bone Density and Allows for Transcrestal Sinus Augmentation Through Compaction Grafting. Int J Oral Maxillofac Implants. 2018 Nov/Dec;33(6):1305-1311. doi: 10.11607/jomi.6770.
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citation: Danesh-Sani SA, Loomer PM, Wallace SS. A comprehensive clinical review of maxillary sinus floor elevation: anatomy, techniques, biomaterials and complications. Br J Oral Maxillofac Surg. 2016 Sep;54(7):724-30. doi: 10.1016/j.bjoms.2016.05.008. Epub 2016 May 25.
citation: Mourao CF, Valiense H, Melo ER, Mourao NB, Maia MD. Obtention of injectable platelets rich-fibrin (i-PRF) and its polymerization with bone graft: technical note. Rev Col Bras Cir. 2015 Nov-Dec;42(6):421-3. doi: 10.1590/0100-69912015006013. English, Portuguese.
citation: Gheno E, Alves GG, Ghiretti R, Mello-Machado RC, Signore A, Lourenco ES, Leite PEC, Mourao CFAB, Sohn DS, Calasans-Maia MD. "Sticky Bone" Preparation Device: A Pilot Study on the Release of Cytokines and Growth Factors. Materials (Basel). 2022 Feb 16;15(4):1474. doi: 10.3390/ma15041474.
citation: Zhou X, Hu XL, Li JH, Lin Y. Minimally Invasive Crestal Sinus Lift Technique and Simultaneous Implant Placement. Chin J Dent Res. 2017;20(4):211-218. doi: 10.3290/j.cjdr.a39220.
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