Effect of photofunctionalization of dental implants on implants stability at an early stage of healing
| ISRCTN | ISRCTN39683834 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39683834 |
| EudraCT/CTIS number | Nil Known |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | Nil Known |
- Submission date
- 17/01/2025
- Registration date
- 20/01/2025
- Last edited
- 20/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Despite the high success rate of treatment with dental implants, the long healing period, especially in poor-quality bone, remains one of the most important limitations of its use. Therefore, efforts continue to reduce this time by improving the surface characteristics of the implant using various physical and chemical methods. UV photofunctionalization is defined as one of the methods of modifying the surface of titanium after UV treatment, including changes in physicochemical properties and improvement of biological features.
Who can participate?
Patients aged 18 years old and over with bilateral edentulous area in the maxilla
What are the possible benefits and risks of participating?
The possible benefits of using photofunctionalization of dental implant surfaces are to gain more implant stability in the early stage of the healing and accelerate osseointegration. However, the possible risks of participating may be related to the stress on the implants which may happen during measuring the implant stability using a dental device.
Where is the study run from?
Oral and Maxillofacial Surgery Hospital, Faculty of Dentistry, Damascus University
When is the study starting and how long is it expected to run for?
December 2021 to December 2024
Who is the funding of the study?
Investigator initiated and funded
Who is the main contact?
Dr Mohammad Kattaa, Mohammed.katta96@gmail.com
Contact information
Public, Scientific, Principal Investigator
Mazzeh Highway
Damascus
0000
Syria
 ORCID ID |
0009-0001-4504-3907 |
|---|---|
| Phone | +963935982622 |
| mohammad96.kattaa@damasucsuniversity.edu.sy |
Public
Mazzeh Highway
Damascus
0000
Syria
| ORCID ID |
0009-0001-4504-3907 |
|---|---|
| Phone | +963949384376 |
| mohammed.katta96@gmail.com |
Study information
| Study design | Double-blind randomized controlled clinical 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, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effect the photofunctionalization on early osseointegration and Implant Stability of titanium dental implants in the maxillary |
| Study objectives | The null hypothesis was that no significant difference exists between the UV-treated and non-treated implants in terms of implant stability in the maxilla |
| Ethics approval(s) |
Approved 02/02/2024, Damascus University (Oral and Maxillofacial Surgery Department, Faculty of Dental Medicine, Damascus University, Damascus, 4671, Syria; +96 11 33923011; verification.dicr@damascusuniversity.edu.sy), ref: DN-020624-237 |
| Health condition(s) or problem(s) studied | Improving the stability of the dental implants in the poor quality bone |
| Intervention | This study is a randomized controlled trial, including 2 groups of implants which will be placed in the same patients - the control group will receive conventional commercial implants, and the experimental group will receive UV-irradiated implants. Implants will be randomized into 2 groups using http://www.randomizer.org/. The follow-up for each patient is 3 months with 4 visits for each patient : 1. 2 weeks postoperative 2. 4 weeks postoperative 3. 8 weeks postoperative 4. 12 weeks postoperative |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Implant stability measured using the Mega ISQ Implant Stability Meter at 5 endpoints: (T0) immediately after surgery, (T1) 2 weeks, (T2) 4 weeks, (T3) 8 weeks, and (T4) 12 weeks |
| Secondary outcome measures | Insertion torque measured using a Torque Ratchet immediately after surgery for all implants |
| Overall study start date | 20/12/2021 |
| Completion date | 19/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 13 |
| Key inclusion criteria | 1. Patients with sufficient residual bone for conventional implant placement 2. Patients with bilateral Edentulous area in the maxilla 3. Patients displaying compliance with oral healthcare instructions and necessary visits |
| Key exclusion criteria | 1. Patients having undergone radiotherapy or with diseases such as osteoporosis that are a contraindication to implant placement 2. Patients with inadequate bone height and width available for implant placement and requiring horizontal or vertical bone augmentation 3. Medically compromised patients with systemic conditions that can impede implant stability and influence the treatment outcome |
| Date of first enrolment | 01/02/2023 |
| Date of final enrolment | 01/02/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
4671
Syria
Sponsor information
University/education
Mazzeh Highway
Damascus
4671
Syria
| Phone | +963944812030 |
|---|---|
| vice.research@damascusuniversity.edu.sy | |
| Website | https://www.damascusuniversity.edu.sy/ |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 19/12/2025 |
|---|---|
| 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
20/01/2025: Study's existence confirmed by the Oral and Maxillofacial Surgery Department, Faculty of Dental Medicine, Damascus University.
