Treatment of gum recession around tooth implants

ISRCTN	ISRCTN75484225
DOI	https://doi.org/10.1186/ISRCTN75484225
Secondary identifying numbers	PS2019001

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Erik Regidor Correa
Scientific

Alameda Urquijo nº 2 - 7ª planta
Bilbao
48008
Spain

ORCID ID	0000-0003-3338-6379
Phone	+34 944158902
Email	erik@ortizvigon.com

Dr Alberto Ortiz-Vigón Carnicero
Scientific

Alameda Urquijo nº 2 - 7ª planta
Bilbao
48008
Spain

ORCID ID	0000-0002-1863-5907
Phone	+34 944158902
Email	alberto@ortizvigon.com

Study information

Study design	Prospective randomized clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	No participant information sheet available
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	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
Secondary outcome measures	1. Esthetic score [ Time Frame: 6 months and 1 year ] measured using esthetic score measured using numeric values from 0 to 10 2. Patient-reported esthetics [ Time Frame: 6 months and 1 year ] measured using patient-reported esthetics measured using numeric values from 1 to 5 3. Patient-reported post-operative pain [ Time Frame: 2 weeks ] measured using patient-reported post-operative pain, based on VAS scale, measured as numbers from 0 to 10. 4. Keratinized tissue (KT) gain [ Time Frame: 6 months and 1 year ] measured using KT gain measured in mm with a manual periodontal probe 5. Keratinized tissue thickness (KTT) [ Time Frame: 6 months and 1 year ] measured using KTT gain measured in mm an intraoral scanning file (STL) and digital software 6. Professional-reported esthetics [ Time Frame: 6 months and 1 year ] measured using blinded examiner reported esthetics measured using numeric values from 1 to 5
Overall study start date	01/06/2021
Completion date	10/06/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	28 patients
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

Periocentrum Bilbao

Alameda Urquijo nº 2 - 7ª planta
Bilbao
48008
Spain

Sponsor information

Oral Reconstruction Foundation
Industry

Margarethenstrasse 38
Basel
CH-4053
Switzerland

Phone	+41 61 565 41 51
Email	info@orfoundation.org
Website	https://orfoundation.org/
"ROR"	https://ror.org/0178qr782

Arrow Development
Research organisation

Alda. Mazarredo 22, 11B
Bilbao
48009
Spain

Phone	+34 662025988
Email	erik@ortizvigon.com

ThinkingPerio Research
Research organisation

Reina Mercedes 17
Madrid
28020
Spain

Phone	+34 91 827 53 06
Email	erikregidor@periocentrum.com
Website	http://www.periocentrum.com

Funders

Funder type

Research organisation

Oral Reconstruction Foundation

No information available

Arrow Development

No information available

ThinkingPerio Research

No information available

Results and Publications

Intention to publish date	01/06/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
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?
Protocol file			20/07/2021	No	No

Additional files

40172_Protocol.pdf

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.