Clinical trial NCT06467630: Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
Official title: Prospective, National, Multicentre and Observational Clinical Investigation of R.T.R.+ Membrane Used in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Guided Bone Regeneration
Keywords: Guided Bone Regeneration
Dental surgical procedures
Lead sponsor: Septodont
Sponsor class: INDUSTRY
First posted: 2024-06-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients are any male and female, adult patients with one of the 3 following dental treatments to be done with the study device:

* post-extraction socket preservation\*,
* alveolar ridge augmentation\*,
* Guided Tissue Regeneration (GTR) during immediate implant placement.

The dental treatment under investigation for one patient could be related to:

* 1 alveolar socket corresponding to only 1 tooth;
* 1 implant to be placed in replacement of 1 tooth;
* several contiguous alveolar sockets;
* Or, several contiguous implants to be placed. Dental treatments done simultaneously in non-contiguous dental zones won't be considered for this study.

Brief summary: The goal of this observational study is to measure in real practice the performance and safety of RTR+Membrane, a synthetic dental membrane for guided tissue regeneration in periodontal or dental implant surgery. The main question it aims to answer is to measure the post-operative wound healing several months after surgery. Participants will be followed after their dental surgery via clinical examination and radiological and photos images.

Detailed description: Participants are any adult patients with one of the 3 following dental treatments to be done with RTR+Membrane:

* post-extraction socket preservation,
* alveolar ridge augmentation,
* Guided Tissue Regeneration (GTR) during immediate implant placement.

Since it is a real-life evidence study in current practice, patients will be followed at their surgery and their follow-ups. Below are listed visits and type of data collected.

* V1 - Surgery: Demography, Medical history and concomitant treatments, Clinical/technical information (tooth extraction, surgery, membrane and grafting materials use), Clinical Exam, Photography, X-rays or Cone Beam Computed Tomography (CBCT)
* V2 - Early follow-up (including suture removal, if needed): Clinical Exam, Questionnaire, Photography
* V2bis - Early follow-up: Clinical Exam, Photography
* V3 - Late follow-up: Clinical Exam, Photography, X-rays or CBCT, Questionnaire

Eligibility criteria: Inclusion Criteria:

* Male or female adult patient
* Patient with one of the 3 following dental treatments to be done with the study device: post-extraction socket preservation, alveolar ridge augmentation, or Guided Tissue Regeneration (GTR) during immediate implant placement.
* Patient affiliated or beneficiary of a social security system.
* Patient has signed his/her informed consent form.

Exclusion Criteria:

* Pregnancy or lactation
* Active tissue infection at the implant site
* Several dental treatments done simultaneously in non-contiguous dental zones
* Heavy smoker (\>10 cigarettes / day)
* Patient receiving long-term corticosteroid therapy, anti-rejection drugs, bisphosphonates, head \& neck radiotherapy or chemotherapy
* Patient with chronic infections (such as osteomyelitis) at the surgical site
* Patient with poorly controlled metabolic disorders (such as diabetes, osteomalacia, thyroid disorders)
* Patient with an auto-immune disease
* Patient under tutelage, vulnerable person, person without liberty, or unable to complete questionnaire independently

Primary outcomes:
measure: Post-operative wound healing measured by the Early Wound-Healing Index
timeFrame: up to 6 months
Secondary outcomes:
measure: Post-operative wound healing measured by Early Wound-Healing Index
timeFrame: up to 14 days
measure: Post-operative wound healing measured by Early Wound Healing Score
timeFrame: up to 14 days
measure: Post-operative clinical exam
timeFrame: up to 6 months
measure: Number of adverse device effects (at least possibly) related to study device
timeFrame: up to 6 months
measure: Oral Health-Related Quality of Life measured by the Oral Health Impact Profile (OHIP-5 items)
timeFrame: up to 6 months
measure: Radiological measurements on CBCT
timeFrame: up to 6 months
measure: Radiological measurements on retro-alveolar radios
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Hospital University of Nantes
city: Nantes
country: France
facility: Private dental practice office of Dr. Alain Hoornaert
city: Nantes
country: France
facility: Private dental practice office of Dr. Samer Saloum-Rouxel
city: Nantes
country: France
facility: Private dental practice office of Dr. Xavier Struillou
city: Nozay
country: France
facility: Private dental practice office of Dr. Edouard Lanoiselée
city: Olonne-sur-Mer
country: France
facility: Private dental practice office of Dr. Aurélien Fruchet
city: Orvault
country: France
facility: Private dental practice office of Dr. Nicolas Strube
city: Orvault
country: France
facility: Private dental practice office of Dr. Romain Besnier
city: Orée d'Anjou
country: France
facility: Private dental practice office of Dr. Hélène Le Hécho
Study officials:
affiliation: University Hospital of Nantes
name: Alain Hoornaert, DDS
role: PRINCIPAL_INVESTIGATOR
References: