Osseodensification Versus Conventional Drilling Effect on Implant Stability

Implant Therapy Clinical Trial

Official title:

The Impact of Osseodensification and Conventional Drilling Protocols on Implants Mechanical and Biological Stability in Posterior Maxilla: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05824949
• Other study ID #: Implant stability
• Status: Completed
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: April 2023
• Source: Arab American University (Palestine)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A total of 80 implants were placed in the posterior region of the maxilla in 40 patients in a split-mouth design. Bone quality was classified into type I, II, III, IV, or V as assessed preoperatively on cone-beam computed tomography (CBCT) . Primary implant stability was measured with insertion torque and resonance frequency analysis (ISQ values). Secondary stability was measured by ISQ at abutment installation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• (a) Bilateral edentulism in the maxillary posterior region dating back more than 6 months,
• (b) sufficient bone height (distance between the bone crest and maxillary sinus >8 mm) and width at the alveolar crest (=6 mm) that would not necessitate bone augmentation,
• (c) at least 2 mm vestibular keratinized mucosa width and 3 mm mucosa thickness,
• (d) full-mouth plaque and bleeding scores <20%.

Exclusion Criteria:

• patients with systemic diseases, conditions, or used medications having the potential to impair surgery, bone, and wound healing dynamics (such as diabetes) will be excluded.
• patients who are allergic to antibiotics and non-steroidal anti-inflammatory drugs
• bone height <8mm
• ridge and soft tissue deficiencies requiring augmentation procedures and
• endodontic or periodontal lesions neighboring the edentulous sites will be also excluded.

Related Conditions & MeSH terms

• Implant Therapy

Intervention

Procedure:
• osseodensification drilling
Implant mechanical and biological stability measured using ISQ values at the time of implant placement and at abutment connection for 40 implants placed in the posterior maxillary area using the osseodensification protocol.
• conventional drilling
Implant mechanical and biological stability measured using ISQ values at the time of implant placement and at abutment connection for 40 implants placed in the posterior maxillary area using the conventional drilling protocol.

Locations

Country	Name	City	State
Palestinian Territory, occupied	Mahmoud Abu-Ta'a	Ramallah

Sponsors (1)

Lead Sponsor	Collaborator
Arab American University (Palestine)

Country where clinical trial is conducted

Palestinian Territory, occupied, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical or primary stability	ISQ values at implant installation	directly after implant placement
Primary	Biological or secondary stability	ISQ values at abutment connection	4 months after implant installation
Secondary	Torque value (N/cm)	Torque value shown at the physiodispenser screen at the end of implant installation	directly after implant insertion