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 |
- Submission date
- 07/06/2025
- Registration date
- 11/06/2025
- Last edited
- 11/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
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
Public, Scientific, Principal Investigator
Damascus city
Damascus
014796
Syria
| Phone | +963 933348895 |
|---|---|
| mazenzenati@gmail.com |
Study information
| Study design | Interventional with one group (before-and-after study) no control group one-center study and single-blinded (statistician) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 | 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) |
| Secondary outcome measures | Implant success after one year using a periodontal probe |
| Overall study start date | 01/09/2022 |
| Completion date | 01/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 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
11259
Syria
Sponsor information
University/education
Almazzeh
Damascus
0036985
Syria
| Phone | +963 1133923192 |
|---|---|
| dl.srd@damascusuniversity.edu.sy | |
| Website | http://www.damascusuniversity.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned to publish in peer-reviewed journals. |
| IPD sharing plan | The datasets generated and analysed during the current study will be publish in the results of the study. |
Editorial Notes
09/06/2025: Trial's existence confirmed by Damascus university.
