L-PRFNCT06719648
Root Coverage for Gingival Recessions: a Randomized Clinical Trial Using Coronally Advanced Tunnel Technique and Novomatrix®
A study testing Acellular dermal matrix + L-Prf and Connective Tissue graft + L-Prf in people with L-PRF and Surgery, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
A randomized clinical trial comparing the modified tunnel technique with the use of acellular xenogeneic matrix and connective tissue with the use leucocyte platlet rich fibrin (L-PRF) Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Acellular dermal matrix + L-Prf and Connective Tissue graft + L-Prf
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 20 May 2020to 28 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years
- Presence of 2 or more adjacent Cairo's type I or II gingival recessions
- Non-smokers
- Plaque index <20% and bleeding on probing (BOP) <20%
- Periodontal health
- Existing endodontic therapies must be carefully evaluated. In case of inadequate treatments, endodontic retreatment will be performed (i.e., a minimum of two months before performing the surgical therapy).
- Use of optical magnification (2.5X) and microsurgical instruments for the surgical procedure is recommended.
Who cannot join
- Individuals who do not meet the inclusion criteria
- Systemic compromise involving healing response and tissue repair, or coagulation disorders
- Uncontrolled systemic diseases
- Use of anticoagulant therapy or bisphosphonates
- Active periodontal disease
- Inadequate psychological profile
- Patients with intentions to change residence that would prevent follow-up
- Multiple recessions in molars
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple Gingival Recessions Root Coverage Using Coronally Advanced Tunnel Technique Combined with a Xenogenic Dermal Matrix (Novomatrix®): a Randomized Clinical Trial
A randomized clinical trial comparing the modified tunnel technique with the use of acellular xenogeneic matrix and connective tissue with the use leucocyte platlet rich fibrin (L-PRF)
Read the detailed description
Study design In the pre-surgical clinical evaluation periodontal measurements were registered at baseline and during the follow-up period: periodontal probing depth (PPD), clinical attachment level (CAL), width and length (mm) of the GR, type of GR, amount of attached gingiva (mm), depth of vestibule (mm), interdental papilla height (mm), non carious cervical lesions, visual LAC detection, gingival thickness (mm) and gingival phenotype (translucency of the periodontal probe). Intraoral photographs always showing a frontal view of the treated area were taken. Moreover, all patients received supragingival scaling and crown polishing. Patient were instructed to rinse with 0.12% Chlorhexidine, 2 times a day for 1 minute starting one week prior to the surgery. Local etiological factors in the area of treatment were controlled or modified, such as the removal and change of overflowing seals, the polishing of restorations, the adjustment of margins. In cases where the cement enamel junction is not clearly detected a reconstruction of this with resin was carried out. Finally, prior to surgery, anti-inflammatory treatment were prescribed to the patient from the day before surgery with Ibuprofen 400 mg, 1 every 8 hours for 7 days
Clinical Procedures:
Prior to surgical procedure, a sealed envelope was opened with the treatment modality (randomization table). Local infiltration anesthesia was performed on both sides (buccal and lingual/palatal) of the affected area. The surgical protocol was performed following the tunnel technique described by Allen (1994) and using microsurgical instruments for periodontal plastic surgery [KPA Allen, PPAELA, tunelisation knife black line, (Hu Fredy)]. The flap was exposed using a modified coronal tunnel technique with partia papillae elevation.
The protocol was started with intra-muscular incisions with an intrasurcular scalpel (KPA Allen) in each of the treated teeth. Elevation of the flap was performed, using the Allen elevator (PPAELA), till the mucogingival line. After reaching this limit, a partial thickness dissection started using the modified Orban knife, until full tension of the flap was eliminated. The interdental papilla's was partially elevated, without being cut from their alveolar base in order to be able to coronally advance the flap to a coronal position free from tension. The flap was extended one tooth mesial and one tooth distal of the treatment area. The separation of the flap from small muscle fibers and bundles of collagen fibers was carefully carried out until the flap can passively be positioned at least 1mm above the cement enamel junction of all the involved teeth, in order to ensure the passive reposition of the flap and the posterior suture free of tension. After assuring the adequate extension of the tunnel, preparation and decontamination of the roots was carried out using Gracey curettes, eliminating the superficial cement surface in relation to the exposed root portion in order to achieve a smooth and flat surface.
All clinical procedures were performed by the same experienced surgeon who was blind to the treatment modality. All evaluations, procedures and controls will be performed in the dental center and pavilions of the Clinic of the Universidad de los Andes and the International University of Cataluña, were two experienced peridontontis (A.C and A.P) will perform the MCAT.
L-PRF procedure protocol Before the beginning of the surgery, 4 tubes of blood without anticoagulant were taken to obtain the L-PRF. This tubes were filled by venous puncture with a butterfly of diameter 24, they were immediately centrifuged at a speed of 2700 rpm for a period of 12 minutes. The tubes were removed from the centrifuge and the result is a fibrin clot with a platelet content located between a layer of lower red blood cells and acellular plasma on the surface, this clot was removed from the tube and the red blood cells adhering to it are removed and discarded. In continuation, the L-PRF clot was placed in a PRF Box (Process Ltd., Nice, France), where it is covered with a compressor. After approximately 1 minute the result is a membrane or autogenous fibrin matrix. Both the Novomatrix matrix and the connective graft will be left in a cup with part of the plasma exudate resulting from the manufacture of the fibrin matrix for a couple of minutes and will be injected with this biological product by injection with tuberculin syringe once positioned under the tunneled flap.
- Being tested
- Acellular dermal matrix + L-Prf, Connective Tissue graft + L-Prf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular dermal matrix + L-PrfDevice
Incisions: Incisions were made in the gums using a specialized scalpel. Flap Elevation: The gum tissue was lifted away from the underlying bone using a dental elevator.
Partial Thickness Dissection: The tissue was cut to release tension and allow for easier repositioning.
Interdental Papilla Elevation: The gum tissue between the teeth was partially lifted.
Flap Extension: The flap was extended to cover more teeth for better coverage. Tissue Separation: The flap was carefully separated from underlying tissues to allow for proper positioning.
Root Preparation: The exposed root surfaces were smoothed and cleaned.
Connective Tissue graft + L-PrfProcedure or surgery
Incisions: Incisions were made in the gums using a specialized scalpel. Flap Elevation: The gum tissue was lifted away from the underlying bone using a dental elevator.
Partial Thickness Dissection: The tissue was cut to release tension and allow for easier repositioning.
Interdental Papilla Elevation: The gum tissue between the teeth was partially lifted.
Flap Extension: The flap was extended to cover more teeth for better coverage. Tissue Separation: The flap was carefully separated from underlying tissues to allow for proper positioning.
Root Preparation: The exposed root surfaces were smoothed and cleaned.
| Study group | Role | What they receive |
|---|---|---|
| Novomatrix and LPRF | Experimental | Incisions: Incisions were made in the gums using a specialized scalpel. Flap Elevation: The gum tissue was lifted away from the underlying bone using a dental elevator.
Partial Thickness Dissection: The tissue was cut to release tension and allow for easier repositioning.
Interdental Papilla Elevation: The gum tissue between the teeth was partially lifted.
Flap Extension: The flap was extended to cover more teeth for better coverage. Tissue Separation: The flap was carefully separated from underlying tissues to allow for proper positioning.
Root Preparation: The exposed root surfaces were smoothed and cleaned. Receives: Device: Acellular dermal matrix + L-Prf |
| Connective tissue graft and LPRF | Active comparator | Incisions: Incisions were made in the gums using a specialized scalpel. Flap Elevation: The gum tissue was lifted away from the underlying bone using a dental elevator.
Partial Thickness Dissection: The tissue was cut to release tension and allow for easier repositioning.
Interdental Papilla Elevation: The gum tissue between the teeth was partially lifted.
Flap Extension: The flap was extended to cover more teeth for better coverage. Tissue Separation: The flap was carefully separated from underlying tissues to allow for proper positioning.
Root Preparation: The exposed root surfaces were smoothed and cleaned. Receives: Procedure: Connective Tissue graft + L-Prf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean root coverage
amount of root surface covered by healthy gum tissue
Measured: Baseline, 6 and 12 months
Secondary outcomes (1)
Complete root coverage
all of the exposed root surface of a tooth has been fully covered by healthy gum tissue
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start20 May 2020
- Primary completion27 Apr 2023
- Study completion28 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for L-PRFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres Pascual La Rocca, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719648
- Sponsor's protocol ID
- PER-ECL-2019-07
- Other IDs
- PER-ECL-2019-07
- Status last verified
- Dec 2024
- First submitted
- 14 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Gingival Recessions Root Coverage Using Coronally Advanced Tunnel Technique Combined with a Xenogenic Dermal Matrix (Novomatrix®): a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06719648
- Acronym / sponsor ID
- PER-ECL-2019-07
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 28 Apr 2024 (actual)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized clinical trial comparing the modified tunnel technique with the use of acellular xenogeneic matrix and connective tissue with the use leucocyte platlet rich fibrin (L-PRF)
Detailed description
Study design In the pre-surgical clinical evaluation periodontal measurements were registered at baseline and during the follow-up period: periodontal probing depth (PPD), clinical attachment level (CAL), width and length (mm) of the GR, type of GR, amount of attached gingiva (mm), depth of vestibule (mm), interdental papilla height (mm), non carious cervical lesions, visual LAC detection, gingival thickness (mm) and gingival phenotype (translucency of the periodontal probe). Intraoral photographs always showing a frontal view of the treated area were taken. Moreover, all patients received supragingival scaling and crown polishing. Patient were instructed to rinse with 0.12% Chlorhexidine, 2 times a day for 1 minute starting one week prior to the surgery. Local etiological factors in the area of treatment were controlled or modified, such as the removal and change of overflowing seals, the polishing of restorations, the adjustment of margins. In cases where the cement enamel junction is not clearly detected a reconstruction of this with resin was carried out. Finally, prior to surgery, anti-inflammatory treatment were prescribed to the patient from the day before surgery with Ibuprofen 400 mg, 1 every 8 hours for 7 days
Clinical Procedures:
Prior to surgical procedure, a sealed envelope was opened with the treatment modality (randomization table). Local infiltration anesthesia was performed on both sides (buccal and lingual/palatal) of the affected area. The surgical protocol was performed following the tunnel technique described by Allen (1994) and using microsurgical instruments for periodontal plastic surgery [KPA Allen, PPAELA, tunelisation knife black line, (Hu Fredy)]. The flap was exposed using a modified coronal tunnel technique with partia papillae elevation.
The protocol was started with intra-muscular incisions with an intrasurcular scalpel (KPA Allen) in each of the treated teeth. Elevation of the flap was performed, using the Allen elevator (PPAELA), till the mucogingival line. After reaching this limit, a partial thickness dissection started using the modified Orban knife, until full tension of the flap was eliminated. The interdental papilla's was partially elevated, without being cut from their alveolar base in order to be able to coronally advance the flap to a coronal position free from tension. The flap was extended one tooth mesial and one tooth distal of the treatment area. The separation of the flap from small muscle fibers and bundles of collagen fibers was carefully carried out until the flap can passively be positioned at least 1mm above the cement enamel junction of all the involved teeth, in order to ensure the passive reposition of the flap and the posterior suture free of tension. After assuring the adequate extension of the tunnel, preparation and decontamination of the roots was carried out using Gracey curettes, eliminating the superficial cement surface in relation to the exposed root portion in order to achieve a smooth and flat surface.
All clinical procedures were performed by the same experienced surgeon who was blind to the treatment modality. All evaluations, procedures and controls will be performed in the dental center and pavilions of the Clinic of the Universidad de los Andes and the International University of Cataluña, were two experienced peridontontis (A.C and A.P) will perform the MCAT.
L-PRF procedure protocol Before the beginning of the surgery, 4 tubes of blood without anticoagulant were taken to obtain the L-PRF. This tubes were filled by venous puncture with a butterfly of diameter 24, they were immediately centrifuged at a speed of 2700 rpm for a period of 12 minutes. The tubes were removed from the centrifuge and the result is a fibrin clot with a platelet content located between a layer of lower red blood cells and acellular plasma on the surface, this clot was removed from the tube and the red blood cells adhering to it are removed and discarded. In continuation, the L-PRF clot was placed in a PRF Box (Process Ltd., Nice, France), where it is covered with a compressor. After approximately 1 minute the result is a membrane or autogenous fibrin matrix. Both the Novomatrix matrix and the connective graft will be left in a cup with part of the plasma exudate resulting from the manufacture of the fibrin matrix for a couple of minutes and will be injected with this biological product by injection with tuberculin syringe once positioned under the tunneled flap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novomatrix and LPRF | Experimental | Device: Acellular dermal matrix + L-PrfIncisions: Incisions were made in the gums using a specialized scalpel. Flap Elevation: The gum tissue was lifted away from the underlying bone using a dental elevator. Partial Thickness Dissection: The tissue was cut to release tension and allow for easier repositioning. Interdental Papilla Elevation: The gum tissue between the teeth was partially lifted. Flap Extension: The flap was extended to cover more teeth for better coverage. Tissue Separation: The flap was carefully separated from underlying tissues to allow for proper positioning. Root Preparation: The exposed root surfaces were smoothed and cleaned. |
| Connective tissue graft and LPRF | Active comparator | Procedure: Connective Tissue graft + L-PrfIncisions: Incisions were made in the gums using a specialized scalpel. Flap Elevation: The gum tissue was lifted away from the underlying bone using a dental elevator. Partial Thickness Dissection: The tissue was cut to release tension and allow for easier repositioning. Interdental Papilla Elevation: The gum tissue between the teeth was partially lifted. Flap Extension: The flap was extended to cover more teeth for better coverage. Tissue Separation: The flap was carefully separated from underlying tissues to allow for proper positioning. Root Preparation: The exposed root surfaces were smoothed and cleaned. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years
- Presence of 2 or more adjacent Cairo's type I or II gingival recessions
- Non-smokers
- Plaque index <20% and bleeding on probing (BOP) <20%
- Periodontal health
Key exclusion criteria (8 listed)
- Individuals who do not meet the inclusion criteria
- Systemic compromise involving healing response and tissue repair, or coagulation disorders
- Uncontrolled systemic diseases
- Use of anticoagulant therapy or bisphosphonates
- Active periodontal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acellular dermal matrix + L-PrfIncisions: Incisions were made in the gums using a specialized scalpel. Flap Elevation: The gum tissue was lifted away from the underlying bone using a dental elevator. Partial Thickness Dissection: The tissue was cut to release tension and allow for easier repositioning. Interdental Papilla Elevation: The gum tissue between the teeth was partially lifted. Flap Extension: The flap was extended to cover more teeth for better coverage. Tissue Separation: The flap was carefully separated from underlying tissues to allow for proper positioning. Root Preparation: The exposed root surfaces were smoothed and cleaned. | Device | Novomatrix and LPRF |
| Connective Tissue graft + L-PrfIncisions: Incisions were made in the gums using a specialized scalpel. Flap Elevation: The gum tissue was lifted away from the underlying bone using a dental elevator. Partial Thickness Dissection: The tissue was cut to release tension and allow for easier repositioning. Interdental Papilla Elevation: The gum tissue between the teeth was partially lifted. Flap Extension: The flap was extended to cover more teeth for better coverage. Tissue Separation: The flap was carefully separated from underlying tissues to allow for proper positioning. Root Preparation: The exposed root surfaces were smoothed and cleaned. | Procedure or surgery | Connective tissue graft and LPRF |
Primary outcome
Mean root coverage
Time frame: Baseline, 6 and 12 months
amount of root surface covered by healthy gum tissue
1 secondary outcome
Complete root coverage
Time frame: Baseline, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acellular dermal matrix + L-Prf and Connective Tissue graft + L-Prf in people with L-PRF and Surgery, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean root coverage (time frame: Baseline, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.