Treatment of gum recession around tooth implants
| ISRCTN | ISRCTN75484225 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75484225 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | PS2019001 |
| Sponsors | Oral Reconstruction Foundation, Arrow Development, ThinkingPerio Research |
| Funders | Oral Reconstruction Foundation, Arrow Development, ThinkingPerio Research |
- Submission date
- 16/07/2021
- Registration date
- 20/07/2021
- Last edited
- 04/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Gum recession is the process in which the tissue that surrounds the teeth pulls away from a tooth, exposing more of the tooth or the tooth's root. This can cause damage to supporting bone. To repair the damage and prevent further dental problems, a gum tissue graft may be needed.
During the procedure, tissue from the roof of your mouth (palate) is removed and then stitched to the gum tissue surrounding the exposed root. An alternative to using your own tissue, NovoMatrix is an acellular dermal matrix consisting of tissue-engineered porcine material.
The aim of this clinical trial is to evaluate the outcomes from performing a graft using the patient's own tissue or NovoMatrix material.
Who can participate?
Adults over 18 years, with receding gums causing bleeding.
What does the study involve?
Participants will be randomly allocated to receive treatment to restore the gum using either the patient's own tissue or using NovoMatrix.
What are the possible benefits and risks of participating?
The main benefit is that patients will see their soft tissue wounds around implants covered.
There is no additional risk of participating, these types of surgical interventions are part of daily routine.
Where is the study run from?
Periocentrum Bilbao (Spain)
When is the study starting and how long is it expected to run for?
June 2021 to June 2024
Who is funding the study?
Oral Reconstruction Foundation (Switzerland)
Arrow Development (Spain)
Who is the main contact?
Dr Erik Regidor Correa, erik@ortizvigon.com
Dr Alberto Ortiz-Vigón Carnicero, alberto@ortizvigon.com
Contact information
Scientific
Alameda Urquijo nº 2 - 7ª planta
Bilbao
48008
Spain
 ORCID ID |
0000-0003-3338-6379 |
|---|---|
| Phone | +34 944158902 |
| erik@ortizvigon.com |
Scientific
Alameda Urquijo nº 2 - 7ª planta
Bilbao
48008
Spain
| ORCID ID |
0000-0002-1863-5907 |
|---|---|
| Phone | +34 944158902 |
| alberto@ortizvigon.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomized clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Coverage of buccal soft tissue dehiscences around implants with an acellular dermal matrix and apical buccal access. Randomized clinical trial |
| Study objectives | The use of acellular dermal matrix in the treatment of buccal soft tissue dehiscences reduces the patient morbidity, surgical intervention time and offers non inferior clinical outcomes |
| Ethics approval(s) | Approved 29/03/2021, Ethical Committee of the Basque Country (CEIm de Euskadi [Comité de Ética de la Investigación Clínica con medicamentos] Farmaziako Zuzendaritza / Dirección de Farmacia. Osasun saila / Departamento de Salud. Eusko Jaurlaritza / Gobierno Vasco C/ Donostia-San Sebastián, 1 – 01010 Vitoria-Gasteiz, Spain; +34 945 01 64 59; ceic.eeaa@euskadi.eus), ref: PS2019001 |
| Health condition(s) or problem(s) studied | Buccal soft tissue dehiscences (recessions) around dental implants |
| Intervention | Surgical intervention: Control group: treatment of buccal soft tissue dehiscences with apical buccal access approach and autologous connective tissue graft. Test group: treatment of buccal soft tissue dehiscences with apical buccal access flap and NovoMatrix. Randomization: Before the surgical intervention. Each subject will randomly assigned with the assistance of computer software to one of the following groups: Control group: treatment of buccal soft tissue dehiscences with apical buccal access approach and autologous connective tissue graft. Test group: treatment of buccal soft tissue dehiscences with apical buccal access approach and NovoMatrix. Postoperative care: Subjects will receive detailed written and verbal post-operative instruction. Subjects will be instructed to avoid mechanical disturbance of the surgical site for the first week. Oral hygiene instructions included 0.12 clorhexidine mouth rinses after 24hours and no direct brushing of the surgical site for one week . All subjects will prescribe oral antibiotics. Azithromycin 250mg 1 per day for 3 days will be the medication of choice. An anti-inflammatory (Enantyum 25mg every 8 hours for 3-5 days) will be prescribed to all subjects. Follow up visits: 2 weeks (photo and patient questionnaire), 4 weeks (photo and patient questionnaire), 12 weeks (photo and patient questionnaire), 6 months (photo, periapical X-ray, patient questionnaire and intraoral scan for volumetric changes, professional questionnaire), 12 months (photo, periapical X-ray, patient questionnaire and intraoral scan for volumetric changes, professional questionnaire). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
The primary outcome will be mean mid-facial recession coverage (mRC) measured as a percentage. Time frame: 6 months and 1 year with an intraoral scanning file (STL) and digital software |
| Key secondary outcome measure(s) |
1. Esthetic score [ Time Frame: 6 months and 1 year ] measured using esthetic score measured using numeric values from 0 to 10 |
| Completion date | 10/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 28 |
| Total final enrolment | 28 |
| Key inclusion criteria | 1. Age ≥18 years 2. Periodontally and systemically healthy 3. Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth) 4. Correct implant 3-dimensional position or buccal position ≤ 1 mm 5. Buccal soft tissue dehiscence ≤4 mm 6. Only osseointegrated implants 7. The patient must be able to perform good oral hygiene |
| Key exclusion criteria | 1. Contraindications for periodontal surgery 2. Patients pregnant or attempting to get pregnant 3. Malpositioned implant 4. Soft tissue dehiscence (STD) >4 mm 5. Existing of peri-implantitis 6. Severe bone loss (≥4mm) 7. Moderate-severe interproximal bone loss (implant fixture level to the alveolar bone >3 mm) 8. Moderate-severe papilla height loss (Nordland and Tarnow implant papillae index >1) 9. Previous mucogingival surgery around the implant within the past six months or implant placement at the surgical site less than six months prior 10. Smoking more than 10 cigarettes a day |
| Date of first enrolment | 01/08/2021 |
| Date of final enrolment | 01/08/2023 |
Locations
Countries of recruitment
- Spain
Study participating centre
Bilbao
48008
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 20/07/2021 | No | No |
Additional files
- 40172_Protocol.pdf
- Protocol file
Editorial Notes
04/12/2024: The intention to publish date was changed from 31/12/2024 to 01/06/2025.
11/06/2024: Total final enrolment added.
10/06/2024: The overall study end date was changed from 31/12/2024 to 10/06/2024.
20/07/2021: Trial's existence confirmed by Ethical Committee of the Basque Country.
