Evaluation of Dental Implants After Using Several Bone Splitting Techniques

Jaw, Edentulous Clinical Trial

Official title:

Evaluation of Clinical and Radiographic Outcomes of Immediate Dental Implants After Using Three Bone Splitting Techniques in Narrow Mandibular Alveolar Ridges: A Randomized Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05720143
• Other study ID #: UDDS-OMFS-01-2023
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: January 12, 2025

Study information

• Verified date: May 2024
• Source: Damascus University
• Contact: ????Ahmad Albassal, MSc
• Phone: 0994391848
• Email: dr.ahmad.bassal.91[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In both full and partial tooth loss, the usage of dental implants for an artificial replacement for missing teeth is a well-known and reasonable treatment modality that leads to high patient satisfaction and enhanced life quality. (1) In both full and partial tooth loss, the usage of dental implants for an artificial replacement for missing teeth is a well-known and reasonable treatment modality that leads to high patient satisfaction and enhanced life quality Because there is insufficient bone volume to support the dimensions of the implants, the horizontal deficiencies of the alveolar ridge obstruct implant-supported rehabilitation, which has an impact on the ultimate prosthetic outcome from both a functional and cosmetic standpoint (2).

The split crest technique reduces treatment time, the number of surgical procedures required, and even the risk of complications for the patients, making it more readily accepted by them. It also allows dental implants to be installed in the same surgical procedure and does not require a donor area to remove the graft. (3) In this study, patients underwent rehabilitation of posterior missing teeth in the narrow mandibular ridge by dental implant after ridge splitting by osseodensification, piezosurgery, or magnetic mallet.

Description:

The study's objective is to compare ridge width gain after osseodensification, piezosurgery, or magnetic mallet after ridge splitting with simultaneous implant implantation in individuals with narrow alveolar ridges.

36 patients will be randomly allocated into three groups. Ridge splitting followed by piezo and bone expander will be performed with simultaneous implant placement in group 1.

osseodensification bure will be performed after ridge splitting with simultaneous implant placement in group 2.

magnetic mallet will be performed after ridge splitting with simultaneous implant placement in group 3.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: January 12, 2025
• Est. primary completion date: December 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Patients who can to follow-up appointments.

2. Alveolar ridge width of at least 3 mm with sufficient height to place a regular implant.

3. Availability of spongy bone with at least 1 mm in width between the cortical plates.

4. Free of any underlying conditions that can impact bone metabolism.

Exclusion Criteria:

1. The presence of severe concavity on the vestibular or palatal side of the alveolar ridge.

2. Patients with uncontrolled periodontal diseases.

3. Patients who have undergone radiotherapy in the head and neck area.

4. Smokers or patients with parafunction habits.

Related Conditions & MeSH terms

• Jaw, Edentulous

Intervention

Procedure:
• Osseodensification
Procedure: the horizontal and vertical osteotomy will make by Piezo and bone splitting will do by osseodensification bur. After that Immediate implantation will be done.
• Magnetic mallet
Procedure: the horizontal and vertical osteotomy will do by Piezo and bone splitting will make by chisels of magnetic mallet. Immediate implantation will be done after splitting.
• Piezo-surgery
Procedure: the horizontal and vertical osteotomy will do by Piezo and bone splitting will make by inserts of piezosurgery and bone expander. Finally, immediate implantation will be placed.

Locations

Country	Name	City	State
Syrian Arab Republic	University of Damascus	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

Bassetti MA, Bassetti RG, Bosshardt DD. The alveolar ridge splitting/expansion technique: a systematic review. Clin Oral Implants Res. 2016 Mar;27(3):310-24. doi: 10.1111/clr.12537. Epub 2015 Jan 14. — View Citation

Buser D, Mericske-Stern R, Bernard JP, Behneke A, Behneke N, Hirt HP, Belser UC, Lang NP. Long-term evaluation of non-submerged ITI implants. Part 1: 8-year life table analysis of a prospective multi-center study with 2359 implants. Clin Oral Implants Res. 1997 Jun;8(3):161-72. doi: 10.1034/j.1600-0501.1997.080302.x. — View Citation

Chiapasco M, Zaniboni M, Boisco M. Augmentation procedures for the rehabilitation of deficient edentulous ridges with oral implants. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:136-59. doi: 10.1111/j.1600-0501.2006.01357.x. — View Citation

Cochran DL, Buser D, ten Bruggenkate CM, Weingart D, Taylor TM, Bernard JP, Peters F, Simpson JP. The use of reduced healing times on ITI implants with a sandblasted and acid-etched (SLA) surface: early results from clinical trials on ITI SLA implants. Clin Oral Implants Res. 2002 Apr;13(2):144-53. doi: 10.1034/j.1600-0501.2002.130204.x. — View Citation

Pozzi A, Mura P. Immediate Loading of Conical Connection Implants: Up-to-2-Year Retrospective Clinical and Radiologic Study. Int J Oral Maxillofac Implants. 2016 Jan-Feb;31(1):142-52. doi: 10.11607/jomi.4061. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The bone width gain	The change in bone width radiographically after ridge splitting. The radiographic measurement by using cone beam computed tomography.	(Time Frame: Baseline, immediately after surgery, and after 4 months of surgery)
Secondary	Implant stability quotients	The score on a scale represents the degree of osseointegration and stability in dental implants by using MEGA Implant Stability Quotient. The scale ranges from 1 to 100, which indicates higher values meaning more excellent stability.	(Time Frame: at the time of surgery and 4 months after surgery)