Refining bone structure for gum defects around teeth
| ISRCTN | ISRCTN81861876 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81861876 |
| Secondary identifying numbers | PS2019009 |
- Submission date
- 23/11/2023
- Registration date
- 28/11/2023
- Last edited
- 06/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Gum problems in the back of your mouth can come with issues like not enough protective gum tissue, shallow spaces between your teeth and cheeks, and unusual tissue connections. When all these oral issues happen at once, fixing them and getting good results for covering exposed tooth roots becomes more challenging. So, it's crucial to carefully choose the right surgical method.
While methods like moving existing tissue and creating a tunnel are well-supported by science, a different technique called apical buccal access (ABA) might have some unique benefits. Adding a special kind of biomaterial called allogeneic cortical lamina to the ABA technique could be a promising solution for combined bone and gum problems.
Our main goal in this study is to check how well this approach works for treating multiple gum recessions.
Who can participate?
Adults over 18 years, with several recessions in the gums near the cheek, and not enough tough gum tissue or depth between the teeth and cheek to keep things healthy. Also, when we look at a special type of X-ray called CBCT, the outer layer of the bone (cortex) is less than 1mm thick.
What does the study involve?
The study does not involve anything else than the treatment of the osseous-mucogingival defect and the routine follow up visits that we perform with or without participating in the study.
What are the possible benefits and risks of participating?
The benefit is that the osseous-mucogingival defect around their teeth will be treated and there is no risk of participating in the study
Where is the study run from?
CLINICA ORTIZ-VIGON (Spain)
When is the study starting and how long is it expected to run for?
September 2019 to September 2025
Who is funding the study?
Arrow Development SL (Spain)
Who is the main contact?
Dr Alberto Ortiz-Vigón, alberto@ortizvigon.com
Dr Erik Regidor, erik@ortizvigon.com
Contact information
Public, Scientific, Principal Investigator
Alameda Urquijo nº 2 - 7ª planta
Bilbao
48008
Spain
 ORCID ID |
0000-0003-3338-6379 |
|---|---|
| Phone | +34 662025988 |
| erik@ortizvigon.com |
Public, Scientific
Alameda Urquijo nº 2 - 7ª planta
Bilbao
48008
Spain
| ORCID ID |
0000-0002-1863-5907 |
|---|---|
| Phone | +34 944158902 |
| alberto@ortizvigon.com |
Study information
| Study design | Prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Dental clinic |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Allogeneic cortical lamina with apical buccal access for combined osseous & mucogingival defects around multiple adjacent teeth |
| Study objectives | The apical buccal access technique combined with a demineralized cortical lamina without modifying the critical zone of the interdental papillae allows adequate root coverage results without compromising vascularization, while achieving an increase in keratinized gingiva and depth, vestibule reducing post-surgical morbidity and intervention time. |
| Ethics approval(s) |
Approved 15/05/2019, Basque Country local ethics committee (Donostia-San Sebastián, 1, Vitoria, 01010, Spain; +34 945 019 303; ceic.eeaa@euskadi.eus), ref: PS2019009 |
| Health condition(s) or problem(s) studied | Multiple vestibular gingival recessions with insufficient keratinized gingiva or vestibule depth for proper maintenance of the teeth. In addition, it must present a cortex less than 1mm on the CBCT. |
| Intervention | First patients coming to periodontal maintenance will be examined. Patients with combined osseous-mucogingival defects around multiple adjacent teeth will be identified in a preliminary exam. In this visit, clinical and radiographic variables will be recorded. Then, the surgical procedure will be performed with allogeneic bone lamina and apical buccal access surgical design. Sutures at 2 weeks will be removed. Follow up visits will be at 3, 6 and 12 months. Periodontal maintenance therapy will be conducted at 6 and 12 months and during these visits, clinical and radiographic variables will be recorded. After 12 months of follow up the study will be finished. Surgical procedure: Buccal apical access flap for the treatment of gingival recessions with Cortiflex® demineralized cortical lamina. DIZG Cortiflex® (allogeneic cortical lamina). In combination with DIZG Cortico-Cancellous Particulate (Cortico-Cancellous Bone 50:50 FDBA Particulate Allograft) for horizontal bone augmentation. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Average recession reduction measured with manual periodontal probe (Hu-Friedy CP15) at baseline, 6 and 12 months. Furthermore, intraoral scan will be recorded. |
| Secondary outcome measures | 1. Complete root coverage measured with manual periodontal probe (Hu-Friedy CP15) at baseline, 6 and 12 months. Furthermore, intraoral scan will be recorded. 2.. Changes in keratinized mucosa measured with manual periodontal probe (Hu-Friedy CP15) at baseline, 6 and 12 months. Furthermore, intraoral scan will be recorded. 3. Changes in vestibulum depth measured with manual periodontal probe (Hu-Friedy CP15) at baseline, 6 and 12 months. Furthermore, intraoral scan will be recorded. 4. Average reduction of the recession measured with manual periodontal probe (Hu-Friedy CP15) at baseline, 6 and 12 months. Furthermore, intraoral scan will be recorded. |
| Overall study start date | 01/09/2019 |
| Completion date | 01/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 15 |
| Total final enrolment | 15 |
| Key inclusion criteria | 1. Informed consent after detailed information 2. Adults at least 18 years of age 3. Patients with multiple recessions (≥2 teeth) type III with shallow vestibule depth and keratinized gingiva that do not include molars, and may be in the upper and lower jaw. 4. Patients who, in the three-dimensional x-ray, present a vestibular cortex less than 1mm thick 5. Healthy or periodontally treated patients 6. Systemically healthy or with completely controlled or stabilized diseases. A medical report will be requested that confirms the stabilization of the specific disease. 7. General plaque control (FMPS) ≤ 25% (O'Leary et al 1972) |
| Key exclusion criteria | 1. Pregnant or breastfeeding patients 2. Uncontrolled medical conditions 3. Uncontrolled periodontal disease 4. Patients treated with any medication that affects gingival conditions such as causing hyperplasia 5. Alcohol and/or drug abuse 6. Do not sign informed consent 7. Despite having root recessions, it presents a cortex greater than 1mm in the 3D CBCT and therefore another type of technique is considered necessary. |
| Date of first enrolment | 01/09/2019 |
| Date of final enrolment | 01/05/2024 |
Locations
Countries of recruitment
- Spain
Study participating centre
Bilbao
48008
Spain
Sponsor information
Research organisation
C/alameda Mazarredo 22 11B
Bilbao
48009
Spain
| Phone | +34 944 15 89 02 |
|---|---|
| cursos@ortizvigon.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Not expected to be made available |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 24/11/2023 | No | No |
Additional files
Editorial Notes
06/03/2024: The Sponsor's email address was corrected.
24/11/2023: Trial's existence confirmed by Basque Country local ethics committee.
