NovoMatrix in Gingival Recession Coverage: Case Series
ConditionGingival Recession, Generalized
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorSemmelweis University
About this trial
Twenty patients seeking treatment for gingival recession coverage, ranging from 20-70 years of age with multiple Miller Class I or II buccal gingival recessions (depth≥3 mm, at least 3 adjacent teeth) will be recruited for this study. Five patients within the study patient pool looking for further orthodontic or restorative treatment that requires removal of one single rooted tooth within the study site of interest will be selected for histological sample removal. All procedures performed in this study will be executed according to established routine protocols, with the exception of block biopsies of one hopeless tooth per patient (total of 5 patients) at 6 months.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female, between 20-70 years of age, who request gingival augmentation or recession coverage.
Subjects who are willing to sign an informed consent, participate and return for follow-up visits.
Subjects without significant medical history and currently not on medications that might complicate treatment outcomes.
Subjects demonstrating good oral hygiene (FMPS, FMBS less than 20%).
Disqualifiers
Subjects who do not meet all the inclusion criteria or who will not cooperate with the protocol schedule.
Subjects who received and failed a previously placed autogenous graft.
Subjects who have significant untreated periodontal disease, caries, infection or chronic inflammation in the oral cavity within two adjacent tooth positions of the clinical trial area.
Subjects who have used nicotine-containing products within 3 weeks prior to surgery.
Trial design
Design model
Single group
Treatments tested in this trial
Subperiostal tunnel in conjunction with Novomatrix
Procedure/SurgeryAn intrasulcular incision on the tooth with recession and on each adjacent tooth. Subperiosteal pouches dissected apically for about 6-8 mm facial to the 3 teeth and connected by extension of the subperiosteal dissection into the interdental areas to create a tunnel. NovoMatrix trimmed to a vertical dimension of 7-8 mm and a horizontal length to completely over the exposed roots and extend laterally to the root line angles of the adjacent teeth. The graft inserted into the tunnel and aligned. Both the overlying tissue and graft positioned 1mm coronally to the level of the cementoenamel junction and secured with a 6-0 resorbable sling suture.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Coronally Advanced Tunnel with NovoMatrixExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Histology
histologically evaluate the quality of newly formed soft tissues 6 months following gingival recession coverage utilizing NovoMatrix.
Time frame
6 monthsSecondary outcomes
1
Postoperative Blood Perfusion changes
Measurements are done by Laser Speckle Contrast Imaging system. Measurements are done at different timepoints. Region of Interests (ROI) are selected and created in PimSoft, the systems own software, which gives a number, called Perfusion Unit, that correlates with the superficial red blood cell movements.
Time frame
Day 0, 1, 4, 7, 10, 14, Month 1, 3, 62
Recession depth
Measured by UNC-15 probe, at the midbuccal surface in mm.
Time frame
Baseline, 1, 3, 6 months and 1 year3
Recession width
Measured by UNC-15 probe, at the midbuccal at the line of CEJ in mm.
Time frame
Baseline, 1, 3, 6 months and 1 year4
Papilla-Contact point distance
Measured by UNC-15 probe in mm.
Time frame
Baseline, 1, 3, 6 months and 1 yearSponsors and contacts
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Source ClinicalTrials.gov