Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement

Maxillary Sinus Floor Augmentation Clinical Trial

Official title:

Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement (A Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495490
• Other study ID #: FDASU-Rec ID032230
• Secondary ID: 1120
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2022
• Est. completion date: January 2024

Study information

• Verified date: November 2022
• Source: Ain Shams University
• Contact: Omneya M. Elkadi, Ass.Lecturer
• Phone: 00201121844448
• Email: ninielkadi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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 ?-?).

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.

Related Conditions & MeSH terms

• Maxillary Sinus Floor Augmentation

Intervention

Procedure:
• Osseodensification Internal Sinus Lift
The osteotomy for the Osseodensification internal sinus lift begins with the advancement of a twist drill at 800 rpm and saline irrigation to within 1-2 mm of the sinus floor. The osteotomy is then widened by employing a series of osteotomy drills rotating at 800 rpm. Infracture of the sinus has occurred when the final osteotomy drill is advanced with gentle pressure at 100 rpm counterclockwise without irrigation until a bouncing sensation ("haptic feedback") occurs. After infracture, the graft material will be injected into the osteotomy site. Using the final osteotomy drill, the graft is guided apically. This procedure is repeated incrementally to raise the membrane. Once sufficient space has been created beneath the antral membrane, the implant will be inserted followed by suturing.
• Osteotome Internal Sinus Lift
The osteotomy for the Osteotome internal sinus lift will begin with standard drills and saline irrigation to prepare the implant socket with a working length that is 1-2 mm shorter than the residual bone height as determined by radiographic examination. After preparation, a series of osteotomes of varying diameters will be sequentially utilized to widen the osteotomy and elevate the Schneiderian membrane by vertical tapping to create a "greenstick" fracture. The Valsalva maneuver (nasal blowing test) will be performed to determine the integrity of the Schneiderian membrane. During the osteotomy, the graft material will be injected and slowly placed into the elevated space using osteotomes until the desired depth is reached. Implant placement and suturing will conclude the procedure.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry- Assiut University	Assiut
Egypt	Faculty of Dentistry- Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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. Review. — View Citation

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. — View Citation

Gheno E, Alves GG, Ghiretti R, Mello-Machado RC, Signore A, Lourenço ES, Leite PEC, Mourão 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). pii: 1474. doi: 10.3390/ma15041474. — View 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. — View Citation

Mourão CF, Valiense H, Melo ER, Mourão 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. — View Citation

Pjetursson BE, Lang NP. Sinus floor elevation utilizing the transalveolar approach. Periodontol 2000. 2014 Oct;66(1):59-71. doi: 10.1111/prd.12043. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Assessment of Change in the Vertical Bone Height (Bone Gain).	The outcome will be obtained by the aid of Computed Cone Beam Tomography, assessing the amount of change from the pre-operative to the post-operative vertical bone height in millimeters.	Pre-operative and Immediately post-operative.
Primary	Radiographic Assessment of Change in the Bone Density.	The outcome will be obtained by the aid of Computed Cone Beam Tomography assessing the amount of change from the pre-operative to the post-operative bone density values in Hounsfield unit.	Pre-operative and Immediately post-operative.
Secondary	Clinical Assessment of Primary Stability of the Implants ( Insertion Torque Value) Measured by a Torque Wrench.	The outcome will be obtained by the aid of a torque wrench and recorded in Newton centimeters.; ( low torque (<30), medium torque (30 < Insertion Torque < 50), and high torque (>50).	During procedure.
Secondary	Clinical Assessment of Primary Stability of the Implants (Implant Stability Quotient ) Measured by an Osstell® Device.	The outcome will be obtained by the aid of an Osstell device, measured by the Resonance Frequency Analysis and determined by the Implant Stability Quotient ( within a 0-100 scale; 100 being maximum implant stability) .	During procedure.
Secondary	Patient's Post-Operative Pain Assessment	The outcome will be obtained by the aid of a 100 mm Visual Analogue Scale (0 = minimal to; 100 = maximum)	1 week post-operative
Secondary	Patient's Satisfaction Assessment.	The outcome will be obtained by the aid of a health-related quality of life questionnaire designed to assess the patient's perception of recovery concerning pain, oral function, general activity, and other symptoms.	1 week post-operative
Secondary	Operator's Satisfaction Assessment	The outcome will be obtained by the aid of a a questionnaire assessing the operator's satisfaction with Osseodensification and Osteotome sinus lift techniques.	1 year