Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06409468 |
| Other study ID # |
Novomatrix |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 5, 2024 |
| Est. completion date |
June 15, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Semmelweis University |
| Contact |
Bálint Molnár, DMD |
| Phone |
0613185222 |
| Email |
molbal81[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
Patient Selection Ten patients requiring gingival recession coverage (Miller Class I or II
with multiple buccal gingival recession ≥3 mm, at least 3 adjacent teeth) will be enrolled
and prepared for surgery in accordance with accepted dental practice guidelines (including
informed consent). The appropriate demographic and medical history, physical examination and
radiographs will be performed and recorded. Other therapies will not be withheld from the
patient if the investigator determines that they are appropriate. Any adverse events will be
recorded and reported on the appropriate case report form. Any and all complications will be
addressed in an appropriate manner at the discretion of the investigator.
Inclusion Criteria
1. Male or female, between 20-70 years of age, who request gingival augmentation or
recession coverage.
2. Subjects who are willing to sign an informed consent, participate and return for
follow-up visits.
3. Subjects without significant medical history and currently not on medications that might
complicate treatment outcomes.
4. Subjects demonstrating good oral hygiene (FMPS, FMBS less than 20%).
Exclusion Criteria
1. Subjects who do not meet all the inclusion criteria or who will not cooperate with the
protocol schedule.
2. Subjects who received and failed a previously placed autogenous graft.
3. 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.
4. Subjects who have used nicotine-containing products within 3 weeks prior to surgery.
5. Subjects who are insulin-dependent diabetic or if their Hgb1c levels > 6.5%.
6. Subjects who have had a history of malignancy within the past 5 years (except for basal
or squamous cell carcinoma of the skin or in situ cervical carcinoma).
7. Subjects who are nursing or pregnant.
8. Subjects who are presently taking medications (except estrogen/progesterone therapy) or
those who are undergoing treatment that in known to have an effect on bone turnover.
9. Subjects who have diseases that affect bone metabolism (excluding idiopathic
osteoporosis).
10. Subjects with a history of an autoimmune disease, documented allergy or multiple
allergies to any component of the agents used in this study.
11. Acutely infected mucogingival defect site.
Gingival Augmentation Procedure All surgical procedures will be performed on an outpatient
basis. A full periodontal and radiographic examination (periapical radiographs) will be
conducted for each patient presurgically. Before surgery, subjects will receive professional
dental cleaning. At the time of surgery, local anesthesia will be administered and the
surgical procedure (estimated to require approximately two hours) will be performed.
Immediately prior to and 1, 3, 6 months after surgery, the following measurements will be
made using a periodontal probe (UNC-15) at the facial aspect of each tooth along the
mucogingival defect extension: plaque index (PI), gingival index (GI), probing depth (PD),
recession depth (RD), recession width (RW) and keratinized tissue width (KW). Keratinized
tissue thickness (KT) will be measured directly using sterile Kerr-files, as well as
indirectly by means of an ultrasonic device (PIROP Biometric scanner G-scan, Echoson,
Poland). Intraoral scanning will be performed to assess surface changes (Emerald, Planmeca,
Finland). Resistance to muscle pull (based on whether the free gingival margin of the tissue
facial to the site moved when the adjacent cheek was retracted) will be evaluated. Pre- and
postoperative blood flow will be assessed using a Laser Speckle Contrast Imaging device
(785nm PeriCam PSI HR System, Perimed AB, Sweden) at Day 0, 1, 4, 7, 10, 14, Month 1, 3, 6.
Any adverse events such as local or systemic reactions will be recorded. After giving both
verbal and written post-surgical instructions to the patient, the investigator will release
the patient when it is medically appropriate.
Pre- and post-surgical clinical examinations will be performed, and oral hygiene instructions
reinforced at each post-surgical visit. Following surgery the patients will be seen at Day 0,
1, 4, 7, 10, 14, Month 1, 3, 6 until biopsy at 6 month post surgery (periapical radiographs
will be taken at baseline and at 6 month).
Block biopsy removal After a healing period of 6 months, a block biopsy will be harvested
under local anesthesia from each patient and immediately immersed in a fixative solution
(estimated to require approximately two hours). The biopsied sites will be repaired with both
hard and soft tissue grafting as necessary. The duration of the proposed study from treatment
(gingival augmentation procedure) to biopsy is up to 6 months.
Implant placement 9 months after biopsy removal implant placement will be carried out in
local anesthesia following mucoperiosteal flap elevation. Alternatively, orthodontic gap
closure or conventional prosthetic reconstruction can be performed depending on individual
needs.
Efficacy Evaluations
Soft Tissue Evaluation Plaque index (PI), gingival index (GI), probing depth (PD), recession
depth (RD), recession width (RW) and keratinized tissue width (KW) will be recorded
immediately prior to and 1, 3, 6 months after surgery. In 5 patients, a block biopsy of
treated tooth will be collected and analyzed.
Pre-Surgical Phase Necessary diagnostic information will be gathered (Clinical photographs,
periapical radiographs and etc.).
Surgical Phase Initial periodontal therapy including oral hygiene instruction and adult
prophylaxis will be performed before the surgery. The surgery will not be performed until
satisfactory plaque control is achieved. The patients will take Amoxicillin 1000mg 1 hour
before surgery, then 2x1000mg daily for the next 7 days. The tooth scheduled for extraction
for either orthodontic or restorative reason will be anesthetized with local anesthesia
(Ultracain DS Forte, Sanofi Aventis, France). Immediately after local anesthesia, root
debridement with hand instruments and removal of the smear layer with an EDTA solution will
be performed. An intrasulcular incision will be made on the tooth with recession and on each
adjacent tooth. Subperiosteal pouches will be 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. The papillae will be separated from the interdental bone crests by
blunt dissection. The tunnel will be extended apically about 6-8 mm by sharp dissection
immediately supraperiosteally flap to ensure the tension-free coronal displacement of the
tunnel. NovoMatrix will be 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 will be inserted into the tunnel and aligned so that the coronal
border of the graft is level with the coronal border of the overlying tissue. Both the
overlying tissue and graft will be positioned 1mm coronally to the level of the cementoenamel
junction and secured with a 6-0 resorbable sling suture (Monolac, Chirmax, Czech Republic;
resorption time 4 weeks). Similar surgical approaches will be rendered for the control group.
Two weeks after surgery the grafted area will be carefully cleaned with 0,2% chlorhexidine
solution (Curasept, Curaden, Sweden). The sutures will be removed at 4 weeks, if necessary.
Patients will be seen at at Day 0, 1, 4, 7, 10, 14, Month 1, 3, 6 until biopsy at 6- month
post surgery to monitor healing and plaque control.
Six months after gingival augmentation procedure, a block biopsy will be harvested under
local anesthesia from each patient. The biopsy area will be reconstructed with both hard and
soft tissue grafting as necessary.
Post-Surgical Care The patients will be instructed not to brush or floss the surgical site(s)
until 2-3 weeks when the graft has become stabilized by healing. Patients will be instructed
to rinse with chlorhexidine mouth rinse (0.2%) 2-3 times daily for 2-3 weeks. Any adverse
effects will be recorded.
Management of Post-Surgical Oral Pain Post-surgical discomfort will be divided into mild,
moderate and severe levels and requires a subjective assessment by the investigator based on
his knowledge of the surgical procedure to be performed and the presenting signs and symptoms
of the patient. Treatment of the source of pain is usually the best management. If infection
is present, treatment of the infection will directly alleviate the patient's discomfort.
The following medications will be given to provide relief follows: 3x400mg Ibuprofen (Advil
Ultra Forte, Pfizer, USA) during the first 2-3 days after surgery. All prescription pain
medications will be closely monitored for efficacy, and dosages altered if the pain persists
or requires a higher level formulation.
Follow-Up Evaluations Patients will be seen for post-operative evaluations at Day 0, 1, 4, 7,
10, 14, Month 1, 3, 6 until the biopsies are obtained. Localized supragingival scaling,
polishing and oral hygiene reinforcement will be performed according to individual needs at
each visit. At 3 and 6 months, periodontal maintenance will be performed which includes an
evaluation of the dental plaque and the gingival condition for the whole mouth. Photographs
of the treated sites will be obtained.
Biopsy All biopsies will be placed into fixative solution (which will be supplied), clearly
labeled and sent via Express Mail or hand delivered to the histological lab. All results and
corresponding documentation, including both histological and clinical findings and
radiographs, should be sent by Express Mail to the histological lab, who will be responsible
for compiling all data and preparation of the final study report.
Study Discontinuation
Participants will be removed from the study prematurely if:
- The subject requests to be withdrawn from the study.
- The principal investigator decides that it is in the subject's best interest.
- The subject is noncompliant with the protocol.
Adverse Events An adverse event is defined as any untoward medical occurrence in a clinical
investigation treatment and does not necessarily have a causal relationship with this
treatment. An adverse event can, therefore, be any unfavorable and unintended sign of
symptom, or disease temporarily associated with the use of an investigational product,
whether or not related to the investigational product. All patients will be prepared for
surgery in accordance with accepted dental practice. The appropriate demographic and medical
history, physical examination, diagnostic laboratory and radiographic work will be performed
and recorded.
Confidentiality All information provided to the Principal Investigator by BioHorizons or
their designates including non-clinical data, protocols, clinical research findings, and
verbal and written information, will be kept strictly confidential and confined to the
clinical personnel involved in conducting the study. It is recognized that this information
may be related in confidence to the Ethics Committee. In addition, no reports or information
about the study or its progress will be provided to anyone not involved in the study other
than to BioHorizons or their designates (if required by law).
Ethical guidelines The study will be carried out in a single center (Department of
Peridontology, Semmelweis University, Budapest, Hungary). Following screening, prior to
surgery, written informed consents will be collected from participants. The study protocol
and written informed consent will be approved by the Semmelweis University's Regional,
Institutional Scientific and Research Ethics Committee.
