Clinical and Radiographic Evaluation of Immediate Implant Placement Using Osseodensification Versus Traditional Drilling Protocol

NCT06307691 | Recruiting DMC

• 1 other identifier: 11423
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

For the purpose of the study, patients will be divided into two groups, i.e., Group A and Group B. In Group (A), 14 immediate implants will be placed using traditional drilling technique, while in Group (B), 14 immediate implants will be placed using OD drilling technique Osseodensification is a system for implant osteotomy preparation, it compresses the cancellous bone around the revolving drills. It largely improves low bone volume by physically increasing the interlocking between the bone and the implant surface. The Densah burs enhances bone density while generating the least amount of heat. Traditional oversized drilling is the regular manufacturer recommended technique of drilling. It functions by cutting the bone during osteotomy preparation by sharp fluted drills. The undersizing of the preparation allows the implant to partially compact the bone during insertion. The objective of the current study is to compare between osseodensification drilling protocol versus traditional undersized drilling protocol in immediate implant placement in anterior maxillary region in terms of implant stability.

Conditions

Implant Complication

Keywords

Implant stability

Outcome Measures

Primary Outcomes (1)

• Implant stability quotient (ISQ)

  resonance frequency analysis

  1 week, 2 week, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks postoperatively.

Secondary Outcomes (1)

• Crestal bone level

  day of the surgery (baseline), at 3 and 6 months postoperatively)

Study Arms (2)

Control: conventional drilling

ACTIVE COMPARATOR

Atraumatic extraction followed by osteotomy preparation. Osteotomy site will be prepared using conventional drills. Implant placement will follow.

Procedure: Conventional drilling

Intervention: Osseodensification

ACTIVE COMPARATOR

Atraumatic extraction followed by osteotomy preparation. Osteotomy site will be prepared using Densah bur. Implant placement will follow.

Procedure: Osseodensification drilling

Interventions

Conventional drilling PROCEDURE

Atraumatic extraction, followed by sequential drilling using conventional drills

Control: conventional drilling

Osseodensification drilling PROCEDURE

Atraumatic extraction, followed by osteotomy prepared using densah bur (sequential drilling)

Intervention: Osseodensification

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients in need of extraction of a single, unrestorable tooth in the esthetic zone including maxillary anteriors and premolars
• Age range between 20-60 years old
• An intact buccal plate of bone after extraction
• Medically free patients (Brightman. 1994)
• Cooperative patients willing to follow up for the duration of the study.

You may not qualify if:

• Acute infection in the implant site
• Patients incapable of maintaining oral hygiene
• Pregnant and nursing female patients
• Smokers (more than 5 cigarettes per day)
• A habit of bruxism
• Periodontal disease
• Subjects who have a systemic disease which affects bone healing as diabetes
• Use of bone metabolism medicines; (Bisphosphonates) .

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Egypt

RECRUITING

Related Publications (12)

• Derks J, Hakansson J, Wennstrom JL, Tomasi C, Larsson M, Berglundh T. Effectiveness of implant therapy analyzed in a Swedish population: early and late implant loss. J Dent Res. 2015 Mar;94(3 Suppl):44S-51S. doi: 10.1177/0022034514563077. Epub 2014 Dec 11.

  PMID: 25503901 BACKGROUND

• Adell R, Lekholm U, Rockler B, Branemark PI. A 15-year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg. 1981 Dec;10(6):387-416. doi: 10.1016/s0300-9785(81)80077-4.

  PMID: 6809663 BACKGROUND

• Schwartz-Arad D, Chaushu G. The ways and wherefores of immediate placement of implants into fresh extraction sites: a literature review. J Periodontol. 1997 Oct;68(10):915-23. doi: 10.1902/jop.1997.68.10.915.

  PMID: 9358358 BACKGROUND

• Gelb DA. Immediate implant surgery: three-year retrospective evaluation of 50 consecutive cases. Int J Oral Maxillofac Implants. 1993;8(4):388-99.

  PMID: 8270307 BACKGROUND

• Agliardi E, Panigatti S, Clerico M, Villa C, Malo P. Immediate rehabilitation of the edentulous jaws with full fixed prostheses supported by four implants: interim results of a single cohort prospective study. Clin Oral Implants Res. 2010 May;21(5):459-65. doi: 10.1111/j.1600-0501.2009.01852.x. Epub 2010 Jan 22.

  PMID: 20105197 BACKGROUND

• Schwartz-Arad D, Grossman Y, Chaushu G. The clinical effectiveness of implants placed immediately into fresh extraction sites of molar teeth. J Periodontol. 2000 May;71(5):839-44. doi: 10.1902/jop.2000.71.5.839.

  PMID: 10872969 BACKGROUND

• Marquezan M, Osorio A, Sant'Anna E, Souza MM, Maia L. Does bone mineral density influence the primary stability of dental implants? A systematic review. Clin Oral Implants Res. 2012 Jul;23(7):767-74. doi: 10.1111/j.1600-0501.2011.02228.x. Epub 2011 Jun 2.

  PMID: 21635560 BACKGROUND

• Farronato D, Manfredini M, Stocchero M, Caccia M, Azzi L, Farronato M. Influence of Bone Quality, Drilling Protocol, Implant Diameter/Length on Primary Stability: An In Vitro Comparative Study on Insertion Torque and Resonance Frequency Analysis. J Oral Implantol. 2020 Jun 1;46(3):182-189. doi: 10.1563/aaid-joi-D-19-00145.

  PMID: 32582919 BACKGROUND

• Greenstein G, Cavallaro J. Implant Insertion Torque: Its Role in Achieving Primary Stability of Restorable Dental Implants. Compend Contin Educ Dent. 2017 Feb;38(2):88-95; quiz 96.

  PMID: 28156122 BACKGROUND

• Trisi P, Berardini M, Falco A, Podaliri Vulpiani M. New Osseodensification Implant Site Preparation Method to Increase Bone Density in Low-Density Bone: In Vivo Evaluation in Sheep. Implant Dent. 2016 Feb;25(1):24-31. doi: 10.1097/ID.0000000000000358.

  PMID: 26584202 BACKGROUND

• Boustany CM, Reed H, Cunningham G, Richards M, Kanawati A. Effect of a modified stepped osteotomy on the primary stability of dental implants in low-density bone: a cadaver study. Int J Oral Maxillofac Implants. 2015 Jan-Feb;30(1):48-55. doi: 10.11607/jomi.3720.

  PMID: 25615915 BACKGROUND

• 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.

  PMID: 27741329 BACKGROUND

Study Officials

• Omar M Ibrahim, Master

  Cairo University

  PRINCIPAL INVESTIGATOR

• Omnia K Tawfik, Lecturer

  Cairo University

  STUDY CHAIR

• Hany El Nahaas, Professor

  Cairo Unversity

  STUDY DIRECTOR

Central Study Contacts

Omar M Ibrahim, Master

CONTACT

010000953710; omar_ibrahim@dentistry.cu.edu.eg

omnia K tawfik, Lecturer

CONTACT

01006002618; omnia.tawfik@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: patients will be randomly selected into either group using computer generated randomization using (www.randomizer.org). The randomized numbers will be allocated to each site in each patient and will be placed in opaque, sealed and sequentially numbered envelopes. patients will be randomly allocated to test and control groups using randomization schedule. Masking/blinding: * Participants will be blinded * Blinding of the operator will be blinded * The outcome assessor will be blinded * The biostatistician will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: March 6, 2024
• Primary Completion: December 20, 2025
• Study Completion (Estimated): December 20, 2026
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

EG (1)