Comparison of piezoelectric surgery with conventional technique in preparing dental implant beds

ISRCTN	ISRCTN25463743
DOI	https://doi.org/10.1186/ISRCTN25463743

Submission date: 07/05/2025
Registration date: 19/05/2025
Last edited: 19/05/2025

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Dental implant treatment involves many invasive procedures, therefore, many studies aim to make it a less traumatic treatment. This study evaluates the effectiveness of piezoelectric surgery, which uses ultrasonic vibrations to perform bone surgery, in reducing postoperative pain and oedema, and improving the dental implant success rate.

Who can participate?
Adult patients who are systemically stable and have bilateral edentulous areas and sufficient alveolar bone volume.

What does the study involve?
The experimental group will receive dental implants using piezoelectric surgery, while the control group will receive the traditional dental implant procedure. The participants will be followed up for 90 days.

What are the possible benefits and risks of participating?
The potential benefits of using piezoelectric surgery include reducing postoperative pain and oedema. However, the potential risks involve a dental implant failure rate of up to 5%.

Where is the study run from?
Oral and Maxillofacial Surgery Hospital, Faculty of Dentistry, Damascus University (Syria).

When is the study starting and how long is it expected to run for?
November 2022 to November 2026

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Mohamad Haroun, mohamad.haroun@damascusuniversity.edu.sy, doctor.mohamadharoun@gmail.com

Contact information

Dr Mohamad Haroun
Public, Scientific, Principal Investigator

Mezzeh Highway
Damascus
0000
Syria

ORCID ID	0009-0001-1522-7203
Phone	+963937622899
Email	mohamad.haroun@damascusuniversity.edu.sy

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	University/medical school/dental school
Study type	Quality of life, Treatment
Participant information sheet	No participant information sheet available
Scientific title	Comparing of piezoelectric surgery with conventional drilling in preparing of dental implant beds: randomized, controlled clinical trial
Study objectives	The null hypothesis posited that there is no a significant difference between piezoelectric surgery and conventional drilling in dental implant stability
Ethics approval(s)	Approved 18/10/2022, Vice President for Scientific Research and Study in Damascus University (Damascus University (Oral and Maxillofacial Surgery Department - Faculty of Dental Medicine) (Mezzeh Highway), Damascus, -, Syria; +963; dean.dent@damascusuniversity.edu.sy), ref: DN-180225-416
Health condition(s) or problem(s) studied	Dental implant insertion in edentulous areas of the mouth
Intervention	This study is a randomized controlled trial, involving piezoelectric surgery tips and conventional drills in dental implant bed preparation. The experimental group received piezoelectric surgery while the control group received the conventional drilling for dental implant bed preparations. Implant stability is measured using a resonance frequency analysis device during the surgery intervention time, after 30, 60 and 90 days. Each group was randomly selected using http://www.randomizer.org/
Intervention type	Procedure/Surgery
Primary outcome measure	Dental implant stability was measured using a resonance frequency analysis device at the surgery intervention time, and at 30, 60 and 90 days
Secondary outcome measures	Pain severity postoperatively in each group was measured using a Visual Analogue Scale (VAS) over 7 days
Overall study start date	18/10/2022
Completion date	30/11/2026

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	20 Years
Upper age limit	60 Years
Sex	Both
Target number of participants	5 patient with 24 implants
Key inclusion criteria	1. Stable medical condition and able to withstand the stress of surgery 2. At least 6 months of teeth extraction healing without any grafting 3. Minimum alveolar bone dimensions required of6mm in width and 12mm in height in both implantation sites
Key exclusion criteria	1. Unstable systemic conditions 2. Harmful oral habits (such as smoking, high load occlusions) 3. A history of radiation, chemical, or bisphosphonate therapy
Date of first enrolment	10/11/2025
Date of final enrolment	13/11/2026

Locations

Countries of recruitment

Syria

Study participating centre

Oral and Maxillofacial Surgery Hospital, Faculty of Dentistry, Damascus University

Mezzeh Highway
Damascus
4671
Syria

Sponsor information

Damascus University
University/education

Mezzeh Highway
Damascus
4671
Syria

Phone	+963 944812030
Email	vice.research@damascusuniversity.edu.sy
Website	https://www.damascusuniversity.edu.sy/
"ROR"	https://ror.org/03m098d13

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	31/12/2026
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a peer-reviewed journal
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Editorial Notes

19/05/2025: Trial's existence confirmed by Damascus University