Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement

Last updated: January 27, 2025
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Osseodensification Internal Sinus Lift

Osteotome Internal Sinus Lift

Clinical Study ID

NCT05495490
FDASU-Rec ID032230
1120
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient partially edentulous with maxillary posterior edentulous ridge afterextraction 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 topreoperative CBCT.

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

Exclusion

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 immunocompromisedstatus.

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

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

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Osseodensification Internal Sinus Lift
Phase:
Study Start date:
February 10, 2025
Estimated Completion Date:
October 31, 2026

Study 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.

Connect with a study center

  • Faculty of Dentistry- Assiut University

    Assiut, 71517
    Egypt

    Active - Recruiting

  • Faculty of Dentistry- Ain Shams University

    Cairo, 11566
    Egypt

    Active - Recruiting

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