Piezoelectric drills for dental implants
| ISRCTN | ISRCTN99951388 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99951388 |
| Secondary identifying numbers | 16CNAHMMDS000002 |
- Submission date
- 08/04/2024
- Registration date
- 09/04/2024
- Last edited
- 10/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Traditional dental implant site preparation methods pose challenges including tissue damage and compromised appearance. Piezosurgery offers a minimally invasive alternative, but its effectiveness is underexplored. This study aims to compare piezosurgery and conventional surgery for dental implant site preparation, focusing on bone density, implant stability, and bone loss.
Who can participate?
Patients aged 18-50 years who are missing at least two teeth, at least one of which is in the back region of the lower jaw
What does the study involve?
Patients are treated sequentially at the two sites where they are missing teeth: at one site implant placement is conducted using piezoelectric surgery and at the other site conventional surgery is used. Post-surgical evaluations were conducted at 6 and 9 months.
What are the possible benefits and risks of participating?
Participants may benefit from receiving dental implants. Possible risks are post-operative complications including pain and swelling.
Where is the study run from?
Army Hospital Research and Referral (India)
When is the study starting and how long is it expected to run for?
December 2016 to October 2023
Who is funding the study?
Army Hospital Research and Referral (India)
Who is the main contact?
Manish Rathi, manishrathi.077h@gov.in
Contact information
Public, Scientific, Principal Investigator
D3-113
NDA Khadakwasla
Pune
411023
India
 ORCID ID |
0000-0002-7689-2506 |
|---|---|
| Phone | +91 (0)9971238331 |
| manishrathi.077h@gov.in |
Study information
| Study design | Single-centre split-mouth interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic, University/medical school/dental school |
| Study type | Treatment |
| Scientific title | Comparative evaluation of piezosurgery versus conventional surgery in dental implants |
| Study objectives | Implant sites prepared with piezoelectric drills are better in terms of implant stability, bone density around implants and patient post-operative recovery. |
| Ethics approval(s) |
Approved 29/09/2016, Army Dental Centre (R&R) Institutional Committee (Dhaula Kuan, New Delhi, 110010, India; +91 (0)9862157110; dental.oc86-ar@gov.in), ref: 16CNAHMMDS000002 |
| Health condition(s) or problem(s) studied | Dental implant |
| Intervention | Thirty patients with two edentulous sites, at least one of which was in the posterior mandibular region, were treated sequentially at two sites: Site A, where implant placement was conducted using piezoelectric surgery, and Site B, where conventional surgery was employed. Post-surgical evaluations were conducted at 6 and 9 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Bone density measured using dual-energy x-ray absorptiometry (DEXA) scan at baseline, 6 and 9 months 2. Implant stability measured using resonance frequency analysis (RFA) scan at baseline and 6 months |
| Secondary outcome measures | Patient’s perception of surgery by measuring postoperative pain using a visual analogue scale (VAS) at 7 days postoperative |
| Overall study start date | 25/12/2016 |
| Completion date | 31/10/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Aged 18 - 50 years 2. Edentulous site in posterior mandibular region 3. Availability of adequate bone volume without any surgical modification |
| Key exclusion criteria | 1. H/o extraction <6 months prior to placement of implant 2. Immunocompromised individual 3. Previous irradiation treatment in head and neck area 4. H/o periodontal disease (active/treated) 5. H/o bone metabolic disorders |
| Date of first enrolment | 16/12/2016 |
| Date of final enrolment | 26/01/2022 |
Locations
Countries of recruitment
- India
Study participating centre
New Delhi
110010
India
Sponsor information
Hospital/treatment centre
Dhaula Kuan
New Delhi
110010
India
| Phone | +91 (0)9862157110 |
|---|---|
| dental.oc86-ar@gov.in | |
"ROR" |
https://ror.org/04zh7mt66 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in high impact peer-reviewed journals |
| IPD sharing plan | Data is saved in a non-publically available repository: the institutional repository of the University of Delhi. The type of data stored: tables, figures, photographs. The process for requesting access (if non-publicly available): contact the corresponding author Manish Rathi (manishrathi.077h@gov.in). |
Editorial Notes
10/09/2024: The following changes were made to the trial record:
1. The ethics approval date was changed from 29/09/2017 to 29/09/2016.
2. The overall end date was changed from 18/12/2018 to 31/10/2023.
3. The recruitment start date was changed from 12/10/2017 to 16/12/2016.
4. The recruitment end date was changed from 26/11/2017 to 26/01/2022.
09/04/2024: Study's existence confirmed by the Army Dental Centre (R&R) Institutional Committee.
