Testing a new type of dental implant for people with severe bone loss in the upper back jaw

ISRCTN	ISRCTN77752182
DOI	https://doi.org/10.1186/ISRCTN77752182
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Damascus University
Funder	Investigator initiated and funded

Submission date: 07/06/2025
Registration date: 11/06/2025
Last edited: 11/06/2025

Recruitment status: No longer recruiting
Overall study status: Completed
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
This study is exploring a new way to help people who have lost a lot of bone in the back part of their upper jaw. Normally, these patients would need a complex surgery called a sinus lift before getting dental implants. This study is testing a different approach using special implants called pterygoid and compressive implants, which can be placed right away without the need for that surgery. The researchers want to see how successful this method is after one year, how much pain it causes, and whether it affects the health of the gums.

Who can participate?
People can take part in the study if they have at least 4 mm of bone width in the premolar area of their upper jaw, and if a specific part of their sinus is located in front of the second premolar.

What does the study involve?
Participants will receive dental implants under local anesthesia. The dentist will make a small cut in the gum, place the implants in the premolar and pterygoid areas, and then stitch the area closed. The implants must be placed with a certain amount of pressure to be included in the study. The researchers will follow up with participants for one year to check how well the implants are working, how much pain they experience, and how their gums respond.

What are the possible benefits and risks of participating?
The main benefit is that participants may receive a full set of upper teeth without needing more invasive surgery. However, as with any dental procedure, there are risks such as pain, swelling, or implant failure. The study will monitor these closely.

Where is the study run from?
Damascus University (Syria)

When is the study starting and how long is it expected to run for?
September 2022 to September 2025.

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Professor Mazen Zenati, mazenzenati@gmail.com

Contact information

Prof Mazen Zenati
Public, Scientific, Principal investigator

Damascus city
Damascus
014796
Syria

Phone	+963 933348895
Email	mazenzenati@gmail.com

Study information

Primary study design	Interventional
Study design	Interventional with one group (before-and-after study) no control group one-center study and single-blinded (statistician)
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Evaluation of Immediate Loading Using Multi Units compressive and pterygoid one piece implants with severe posterior maxillary atrophy
Study objectives	1. Pterygoid implants will be sufficient and successful. 2. Pterygoid implants will serve as an alternative to external sinus lifts.
Ethics approval(s)	Approved 22/04/2025, Scientific Research and Postgraduate Studies Council (Baramkeh, Damascus, 00258, Syria; +963 1133923192; ap.srd@damascusuniversity.edu.sy), ref: DN-150425-H25
Health condition(s) or problem(s) studied	Severe bone deficiency in the posterior region of the maxilla
Intervention	The participants will be treated under local anesthesia by using lidocaine with epinephrine 1:80,000. An incision will be made along the crest, and a full-thickness flap will be elevated. Implants will be placed in the premolars and pterygoid regions. Pterygoid and premolar implants should attain an insertion torque of at least 45 Ncm to be included in the study. Suture the incision using 4/0 nylon sutures with a reversed cutting needle.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	1. Insertion torque using ratchet (at baseline) 2. Pain levels using VAS (daily in the first 7 days) 3. Plaque Score and Gingival Index using Periodontal probe (after 7 days, 3 months, 6 months, 9 months, and 12 months)
Key secondary outcome measure(s)	Implant success after one year using a periodontal probe
Completion date	01/09/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	20
Total final enrolment	20
Key inclusion criteria	1. Presence of bone width 4 mm in premolar area. 2. Inferior corner of the anterior wall of the sinus positioned anterior to the second premolar.
Key exclusion criteria	1. Patients with bruxism and/or clenching. 2. Presence of systemic uncontrolled diseases that could represent a general contraindication to put implants. 3. Ongoing maxillary radiation therapy. 4. Active chemotherapy.
Date of first enrolment	01/01/2023
Date of final enrolment	01/01/2025

Locations

Countries of recruitment

Syria

Study participating centre

Damascus University

Fayez Mansour st, Almazzah
Damascus
11259
Syria

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
IPD sharing plan	The datasets generated and analysed during the current study will be publish in the results of the study.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

09/06/2025: Trial's existence confirmed by Damascus university.