A new technique for better healing of patients seeking oral rehabilitation with implants
| ISRCTN | ISRCTN10220098 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10220098 |
| Secondary identifying numbers | CEEM-10-2022 |
- Submission date
- 11/01/2023
- Registration date
- 05/05/2023
- Last edited
- 12/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Not infrequently, certain surgical procedures are required to contribute to successful bone regeneration in the mouth, increasing the level of bone and allowing a better chance for dental implants to be successfully placed. The aim of this study is to assess a new surgical technique with less damage for better healing of patients seeking oral rehabilitation with implants compared with a standard surgical technique.
Who can participate?
Patients aged 21 years and over with some missing teeth requiring surgery to reestablish a certain level of bone inside the mouth for dental implant placement
What does the study involve?
Patients will be randomly allocated to either the new oral surgical technique or the usual technique for bone regeneration of mouth locations that will receive dental implants.
What are the possible benefits and risks of participating?
The possible benefits are the preparation of a local oral site that will be better prepared to receive a dental implant, with the associated risks being those expected in oral surgeries: temporary symptoms and signs of pain, discomfort, swelling, and bleeding.
Where is the study run from?
Egas Moniz Dental Clinic (Portugal)
When is the study starting and how long is it expected to run for?
July 2022 to September 2025
Who is funding the study?
Egas Moniz School of Health and Sciences (Portugal)
Who is the main contact?
João Botelho, jbotelho@egasmoniz.edu.pt
Contact information
Scientific
Campus Universitário
Quinta da Granja
Monte da Caparica
Almada
2829-511
Portugal
 ORCID ID |
0000-0002-1019-8263 |
|---|---|
| Phone | +351 (0)212946840 |
| jbotelho@egasmoniz.edu.pt |
Principal Investigator
Oude Markt 13, 3000
Leuven
3000
Belgium
| Phone | +32 (0)16 32 40 10 |
|---|---|
| andy.temmerman@kuleuven.be |
Study information
| Study design | Prospective randomized controlled multi-arm parallel-group double-blinded clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The modified cut-back incision technique to attain tension-free primary closure: a randomized controlled clinical trial |
| Study acronym | mCASTing |
| Study objectives | This new technique, named modified-cutback advancement surgical technique (mCAST), has fewer complications compared to the periosteal releasing incision. |
| Ethics approval(s) | Approved 29/09/2022, Egas Moniz Ethics Committee (Campus Universitário, Quinta da Granja Monte da Caparica 2829-511, Almada, Portugal; +351 (0)212946767, iuem@egasmoniz.edu.pt), ref: 1117/2022 |
| Health condition(s) or problem(s) studied | Partially edentulous patients requiring guided bone regeneration |
| Intervention | Each participant will be assigned in ascending order at the enrolment visit. Patients will be randomly assigned in a 1:1 ratio to either the test group (mCAST) or the control group (classic periosteal releasing incision) using an online randomization tool (https://www.randomizer.org/). Allocation concealment will be done with opaque envelopes, which will be opened by the surgeon immediately after the procedure. The sequence of envelopes will be done, a priori, by a non-involved researcher. mCAST: 1. A crestal, slightly vestibular incision is performed in the area of augmentation 2. One or two vertical releasing incisions are performed, two teeth from the defect, in a wide manner, to make the base of the flap as wide as possible 3. A full-thickness flap is raised 4. After performing the augmentation procedure, cut-back incisions are performed at 60° towards the centre of the flap, thereby releasing the muscle tension. Depending on the amount of advancement necessary these cut-back incisions can be prolonged 5. Horizontal mattress sutures (dense polytetrafluoroethylene [d-PTFE]) are used to stabilize the flap 6. Suturing is started crestally and thereafter the releasing incisions are sutured starting apically |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Flap advancement measured in mm using a UNC 15 periodontal probe. The flap was extended with minimum tension while the probe was positioned perpendicular to the crest of the ridge and kept parallel to the flap direction The readings should be taken at the mesial, middle, and distal parts of the flap, for each part the advancement measured three times and an average of the three readings is recorded by a single examiner. |
| Secondary outcome measures | Postoperative pain is recorded using the Numerical Rating scale (NRS) and postoperative swelling is recorded using the Visual Analogue Scale (VAS). Both scores are recorded for 7 days postoperatively and are collected from the patients on the suture removal visit. Postoperative swelling is scored as follows: 1. None (no swelling) 2. Mild intraoral swelling confined to the surgical zone 3. Moderate intraoral swelling confined to the surgical zone 4. Intense (extraoral swelling spreading beyond the surgical zone) |
| Overall study start date | 01/07/2022 |
| Completion date | 01/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 21 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Systemically healthy 2. ≥ 21 years of age 3. Partially edentulous in the maxilla with 1-2 missing teeth 4. Insufficient ridge width (<5 mm), no evidence of vertical loss 5. Adequate soft tissue phenotype (≥2 mm and ≤4 mm of thickness) and a minimum of 2 mm of buccal keratinized tissue 6. Presence of proper inter-arch space for implant prosthesis placement 7. No clinical evidence of active periodontal disease or oral infections |
| Key exclusion criteria | 1. Systemic conditions that may interfere with the results (e.g., diabetes mellitus) 2. Local pathological defects 3. Unmotivated, uncooperative patients with poor oral hygiene 4. Habits that may jeopardize the implant longevity (e.g., smoking, alcoholism, or para-functional habits) 5. Bone-associated diseases or medication affecting bone metabolism (e.g., bisphosphonates) 6. History of radiation or chemotherapy 7. Inflammatory and autoimmune diseases 8. Shallow vestibular depth 9. History of oral surgery in the region of interest, which might have scared the periosteum |
| Date of first enrolment | 23/01/2023 |
| Date of final enrolment | 01/05/2025 |
Locations
Countries of recruitment
- Portugal
Study participating centre
Monte da Caparica
Almada
2829-511
Portugal
Sponsor information
University/education
Campus Universitário
Quinta da Granja
Monte da Caparica
Almada
2829-511
Portugal
| Phone | +351 (0)212946806 |
|---|---|
| jmendes@egasmoniz.edu.pt | |
| Website | https://legacy.egasmoniz.com.pt/pt-pt.aspx |
"ROR" |
https://ror.org/01prbq409 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | The researchers intend to publish the results and associated data in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during the current study will be stored in a publicly available repository. The name of the repository: Open Science Framework (OSF) The type of data stored: Excel data The process for requesting access: full access without request Dates of availability: on a regular basis Whether consent from participants was required and obtained: it will be accounted for Comments on data anonymization: data will be anonymized Any ethical or legal restrictions: none Any additional comments: none |
Editorial Notes
12/01/2023: Trial's existence confirmed by the Egas Moniz Ethics Committee.
