Clinical trial NCT05720143: Evaluation of Dental Implants After Using Several Bone Splitting Techniques
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Jaw, Edentulous
Keywords: Osseodensification
Piezosurgery
Magnetic mallet
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The crestal bone loss
timeFrame: (Time Frame: Baseline, immediately after surgery, after 4 months of surgery, and after 6 months of functional loading.)
Secondary outcomes:
measure: Implant stability quotients
timeFrame: (Time Frame: at the time of surgery and 4 months after surgery)
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: University of Damascus
Study officials:
affiliation: Department of Oral and Maxillofacial Surgery, University of Damascus Faculty of Dentistry, Damascus
name: Ahmad Albassal, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Oral and Maxillofacial Surgery, University of Damascus Faculty of Dentistry, Damascus
name: Munir Harfouch, MSc PhD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
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.
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.