Gingival RecessionNCT03533933
Clinical and Histomorphometric Analysis of Collagen Matrix Versus Connective Tissue Graft in Mucogingival Surgery in Orthodontic Patients
A study testing Collagen matrix and autologous connective tissue graft in people with Gingival Recession, run by Elena Ruiz de Gopegui Palacios at 1 site in Spain.
Trial summary
There are some orthodontics treatments that perform risk movements ,and a bone dehiscence may be expected. In that cases mucogingival surgery , such as connective tissue grafts, is necessary prior to tooth movement. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Collagen matrix and autologous connective tissue graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2018to 1 Jun 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient in orthodontic treatment ,who needs mucogingival surgery in both hemi arcade and later the tooth adjacent to the graft should be extracted because of the orthodontic planing treatment .
- The patient must be 18 years or older
- Patient shows sufficient plaque control (FMPS < 20%).
- The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent
Who cannot join
- General contraindications for dental and/or surgical treatment are present.
- The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
- Untreated periodontal conditions
- Patients not willing to participate
Trial locations and contacts
1 site in 1 country.
Ana Maria Garcia de la Fuente contact
Spain1 site, 1 recruiting
- Recruiting
Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country
Leioa, Biscay, 48940
Elena Ruiz de Gopegui Palacios, 0034649547011, helenruizdegopegui@gmail.com
Ana Maria Garcia de la Fuente, anamaria.garciad@ehu.es
About this study
Official title: Clinical and Histomorphometric Analysis of Collagen Matrix Versus Connective Tissue Graft in Mucogingival Surgery in Orthodontic Patients. A Randomized, Controlled Clinical Trial
There are some orthodontics treatments that perform risk movements ,and a bone dehiscence may be expected. In that cases mucogingival surgery , such as connective tissue grafts, is necessary prior to tooth movement.
The connective tissue graft in combination with coronal advanced flap is still considered the gold standard , although the use of porcine collagen matrix has obtained promising results for treatment of Miller class I and II recession defects.
Read more
Most of the studies report clinical results after a connective tissue graft and there is no evidence about the type of attachment obtained after the graft is performed, a few articles have shown histological results. But, as a rule , a histological study is only performed under exceptional circumstances such as a dental fracture, untreatable decay, tooth extraction for orthodontic reasons, or other reasons.
Most of the techniques results in the formation of a long junctional epithelium and connective tissue attachment with fibers parallel to the root surface. Animals studies have shown a shorter epithelium and a larger new cementum formation after the use of the collagen matrix.
Read the detailed description
The purpose of this study is to confirm that periodontal regeneration happens after mucogingival surgery The principal outcome is compare the millimeters of new attachment create after a connective tissue graft and after the use of a porcine collagen matrix in teeth that have to been extracted (because of the orthodontic planing treatment) after mucogingival surgery .
The secondary outcomes are:
- length of new cementum (histometry results)
- length of the junctional epithelium (histometry results)
- length of connective tissue attachment (histometry results)
- complete root coverage (clinical results)
- width of keratinized tissue
- Conditions
- Gingival Recession
- Being tested
- Collagen matrix, autologous connective tissue graft
- Keywords
- collagen matrix, connective tissue graft, histometry, xenograft, periodontal regeneration, biometry
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen matrixDevice
Mucograft collagen matrix combined with coronal advanced flap
autologous connective tissue graftOther
Soft tissue harvesting from patient palate with coronal advanced flap
| Study group | Role | What they receive |
|---|---|---|
| Autologous connective tissue graft | Active comparator | Soft tissue harvesting from patient palate Receives: Other: autologous connective tissue graft |
| collagen matrix | Experimental | Mucograft collagen matrix manufactured by Geistlich AG, Switzerland Device: Collagen matrix Receives: Device: Collagen matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
millimeters of new attachment
histometry assessment
Measured: Change from baseline at following surgery sixth month
Secondary outcomes (5)
Length of new cementum
histometry assessment
Measured: Change from baseline at following surgery sixth month
Length of new junctional epithelium
histometry assessment
Measured: Change from baseline at following surgery sixth month
length of connective attachment
histometry assessment
Measured: Change from baseline at following surgery sixth month
complete root coverage
clinical assessment
Measured: Change from baseline at following surgery sixth month
width of keratinized tissue
clinical assessment
Measured: Change from baseline at following surgery sixth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Sep 2018
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies 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
- Model description
- Split mouth
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elena Ruiz de Gopegui Palacios
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elena Ruiz de Gopegui Palacios, University of the Basque Country (UPV/EHU)
- Investigators
- Luis Antonio Aguirre Zorzano, Study director, University of the Basque Country (UPV/EHU)Elena Ruiz de Gopegui, Principal investigator, University of the Basque Country (UPV/EHU)Ana Maria Garcia de la Fuente, Principal investigator, University of the Basque Country (UPV/EHU)Ruth Estefania Fresco, Study chair, University of the Basque Country (UPV/EHU)Xavier Marichalar Mendia, Study chair, University of the Basque Country (UPV/EHU)Jose Manuel Aguirre Urizar, Study chair, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533933
- Sponsor's protocol ID
- MCP-2
- Status last verified
- Jul 2019
- First submitted
- 10 May 2018
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data collected for the study will be identified by a code and only the researcher will be able to relate them. The personal data will be treated with absolute confidentiality in accordance with the Data Protection Law and will remain in the patient's clinical history. The coded data will be included in a UPV/EHU´s file with reference number 2080310015-INA0110, whose head is Ana María García de la Fuente, and will only be used for the purposes of this project.
Publications
Batenhorst KF, Bowers GM, Williams JE Jr. Tissue changes resulting from facial tipping and extrusion of incisors in monkeys. J Periodontol. 1974 Sep;45(9):660-8. doi: 10.1902/jop.1974.45.9.660. No abstract available.
PubMed 4529575Steiner GG, Pearson JK, Ainamo J. Changes of the marginal periodontium as a result of labial tooth movement in monkeys. J Periodontol. 1981 Jun;52(6):314-20. doi: 10.1902/jop.1981.52.6.314.
PubMed 6943326Wennstrom JL, Lindhe J, Sinclair F, Thilander B. Some periodontal tissue reactions to orthodontic tooth movement in monkeys. J Clin Periodontol. 1987 Mar;14(3):121-9. doi: 10.1111/j.1600-051x.1987.tb00954.x.
PubMed 3470318Buti J, Baccini M, Nieri M, La Marca M, Pini-Prato GP. Bayesian network meta-analysis of root coverage procedures: ranking efficacy and identification of best treatment. J Clin Periodontol. 2013 Apr;40(4):372-86. doi: 10.1111/jcpe.12028. Epub 2013 Jan 24.
PubMed 23346965Cairo F, Pagliaro U, Nieri M. Treatment of gingival recession with coronally advanced flap procedures: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):136-62. doi: 10.1111/j.1600-051X.2008.01267.x.
PubMed 18724847Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects? J Dent. 2008 Sep;36(9):659-71. doi: 10.1016/j.jdent.2008.05.007. Epub 2008 Jun 26.
PubMed 18584934Thoma DS, Benic GI, Zwahlen M, Hammerle CH, Jung RE. A systematic review assessing soft tissue augmentation techniques. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:146-65. doi: 10.1111/j.1600-0501.2009.01784.x.
PubMed 19663961Thoma DS, Muhlemann S, Jung RE. Critical soft-tissue dimensions with dental implants and treatment concepts. Periodontol 2000. 2014 Oct;66(1):106-18. doi: 10.1111/prd.12045.
PubMed 25123764Soileau KM, Brannon RB. A histologic evaluation of various stages of palatal healing following subepithelial connective tissue grafting procedures: a comparison of eight cases. J Periodontol. 2006 Jul;77(7):1267-73. doi: 10.1902/jop.2006.050129.
PubMed 16805692Griffin TJ, Cheung WS, Zavras AI, Damoulis PD. Postoperative complications following gingival augmentation procedures. J Periodontol. 2006 Dec;77(12):2070-9. doi: 10.1902/jop.2006.050296.
PubMed 17209793Wessel JR, Tatakis DN. Patient outcomes following subepithelial connective tissue graft and free gingival graft procedures. J Periodontol. 2008 Mar;79(3):425-30. doi: 10.1902/jop.2008.070325.
PubMed 18315424Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial. J Periodontol. 2012 Mar;83(3):321-8. doi: 10.1902/jop.2011.110215. Epub 2011 Jul 1.
PubMed 21721988Aroca S, Molnar B, Windisch P, Gera I, Salvi GE, Nikolidakis D, Sculean A. Treatment of multiple adjacent Miller class I and II gingival recessions with a Modified Coronally Advanced Tunnel (MCAT) technique and a collagen matrix or palatal connective tissue graft: a randomized, controlled clinical trial. J Clin Periodontol. 2013 Jul;40(7):713-20. doi: 10.1111/jcpe.12112. Epub 2013 Apr 30.
PubMed 23627374Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10.
PubMed 23050490Molnar B, Aroca S, Keglevich T, Gera I, Windisch P, Stavropoulos A, Sculean A. Treatment of multiple adjacent Miller Class I and II gingival recessions with collagen matrix and the modified coronally advanced tunnel technique. Quintessence Int. 2013 Jan;44(1):17-24. doi: 10.3290/j.qi.a28739.
PubMed 23444157
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histomorphometric Analysis of Collagen Matrix Versus Connective Tissue Graft in Mucogingival Surgery in Orthodontic Patients. A Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03533933
- Acronym / sponsor ID
- MCP-2
- Conditions
- Gingival Recession
- Keywords
- collagen matrix, connective tissue graft, histometry, xenograft, periodontal regeneration, biometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Elena Ruiz de Gopegui PalaciosUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 23 May 2018 (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.
There are some orthodontics treatments that perform risk movements ,and a bone dehiscence may be expected. In that cases mucogingival surgery , such as connective tissue grafts, is necessary prior to tooth movement.
The connective tissue graft in combination with coronal advanced flap is still considered the gold standard , although the use of porcine collagen matrix has obtained promising results for treatment of Miller class I and II recession defects.
Most of the studies report clinical results after a connective tissue graft and there is no evidence about the type of attachment obtained after the graft is performed, a few articles have shown histological results. But, as a rule , a histological study is only performed under exceptional circumstances such as a dental fracture, untreatable decay, tooth extraction for orthodontic reasons, or other reasons.
Most of the techniques results in the formation of a long junctional epithelium and connective tissue attachment with fibers parallel to the root surface. Animals studies have shown a shorter epithelium and a larger new cementum formation after the use of the collagen matrix.
Detailed description
The purpose of this study is to confirm that periodontal regeneration happens after mucogingival surgery The principal outcome is compare the millimeters of new attachment create after a connective tissue graft and after the use of a porcine collagen matrix in teeth that have to been extracted (because of the orthodontic planing treatment) after mucogingival surgery .
The secondary outcomes are:
- length of new cementum (histometry results)
- length of the junctional epithelium (histometry results)
- length of connective tissue attachment (histometry results)
- complete root coverage (clinical results)
- width of keratinized tissue
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth
| Arm | Type | Receives |
|---|---|---|
| Autologous connective tissue graft | Active comparator | Other: autologous connective tissue graftSoft tissue harvesting from patient palate |
| collagen matrix | Experimental | Device: Collagen matrixMucograft collagen matrix manufactured by Geistlich AG, Switzerland Device: Collagen matrix |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient in orthodontic treatment ,who needs mucogingival surgery in both hemi arcade and later the tooth adjacent to the graft should be extracted because of the orthodontic planing treatment .
- The patient must be 18 years or older
- Patient shows sufficient plaque control (FMPS < 20%).
- The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent
Key exclusion criteria (4 listed)
- General contraindications for dental and/or surgical treatment are present.
- The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
- Untreated periodontal conditions
- Patients not willing to participate
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 |
|---|---|---|
| Collagen matrixMucograft collagen matrix combined with coronal advanced flap | Device | collagen matrix |
| autologous connective tissue graftSoft tissue harvesting from patient palate with coronal advanced flap | Other | Autologous connective tissue graft |
Primary outcome
millimeters of new attachment
Time frame: Change from baseline at following surgery sixth month
histometry assessment
5 secondary outcomes
Length of new cementum
Time frame: Change from baseline at following surgery sixth month
Length of new junctional epithelium
Time frame: Change from baseline at following surgery sixth month
length of connective attachment
Time frame: Change from baseline at following surgery sixth month
complete root coverage
Time frame: Change from baseline at following surgery sixth month
width of keratinized tissue
Time frame: Change from baseline at following surgery sixth month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Background: PubMed 4529575Batenhorst KF, Bowers GM, Williams JE Jr. Tissue changes resulting from facial tipping and extrusion of incisors in monkeys. J Periodontol. 1974 Sep;45(9):660-8. doi: 10.1902/jop.1974.45.9.660. No abstract available.
- Background: PubMed 6943326Steiner GG, Pearson JK, Ainamo J. Changes of the marginal periodontium as a result of labial tooth movement in monkeys. J Periodontol. 1981 Jun;52(6):314-20. doi: 10.1902/jop.1981.52.6.314.
- Background: PubMed 3470318Wennstrom JL, Lindhe J, Sinclair F, Thilander B. Some periodontal tissue reactions to orthodontic tooth movement in monkeys. J Clin Periodontol. 1987 Mar;14(3):121-9. doi: 10.1111/j.1600-051x.1987.tb00954.x.
- Background: PubMed 23346965Buti J, Baccini M, Nieri M, La Marca M, Pini-Prato GP. Bayesian network meta-analysis of root coverage procedures: ranking efficacy and identification of best treatment. J Clin Periodontol. 2013 Apr;40(4):372-86. doi: 10.1111/jcpe.12028. Epub 2013 Jan 24.
- Background: PubMed 18724847Cairo F, Pagliaro U, Nieri M. Treatment of gingival recession with coronally advanced flap procedures: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):136-62. doi: 10.1111/j.1600-051X.2008.01267.x.
- Background: PubMed 18584934Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects? J Dent. 2008 Sep;36(9):659-71. doi: 10.1016/j.jdent.2008.05.007. Epub 2008 Jun 26.
- Background: PubMed 19663961Thoma DS, Benic GI, Zwahlen M, Hammerle CH, Jung RE. A systematic review assessing soft tissue augmentation techniques. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:146-65. doi: 10.1111/j.1600-0501.2009.01784.x.
- Background: PubMed 25123764Thoma DS, Muhlemann S, Jung RE. Critical soft-tissue dimensions with dental implants and treatment concepts. Periodontol 2000. 2014 Oct;66(1):106-18. doi: 10.1111/prd.12045.
- Background: PubMed 16805692Soileau KM, Brannon RB. A histologic evaluation of various stages of palatal healing following subepithelial connective tissue grafting procedures: a comparison of eight cases. J Periodontol. 2006 Jul;77(7):1267-73. doi: 10.1902/jop.2006.050129.
- Background: PubMed 17209793Griffin TJ, Cheung WS, Zavras AI, Damoulis PD. Postoperative complications following gingival augmentation procedures. J Periodontol. 2006 Dec;77(12):2070-9. doi: 10.1902/jop.2006.050296.
- Background: PubMed 18315424Wessel JR, Tatakis DN. Patient outcomes following subepithelial connective tissue graft and free gingival graft procedures. J Periodontol. 2008 Mar;79(3):425-30. doi: 10.1902/jop.2008.070325.
- Background: PubMed 21721988Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial. J Periodontol. 2012 Mar;83(3):321-8. doi: 10.1902/jop.2011.110215. Epub 2011 Jul 1.
- Individual participant dataSharing planned: Yes. The data collected for the study will be identified by a code and only the researcher will be able to relate them. The personal data will be treated with absolute confidentiality in accordance with the Data Protection Law and will remain in the patient's clinical history. The coded data will be included in a UPV/EHU´s file with reference number 2080310015-INA0110, whose head is Ana María García de la Fuente, and will only be used for the purposes of this project.
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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.
Ana Maria Garcia de la Fuente contact
Luis Antonio Aguirre Zorzano study director
University of the Basque Country (UPV/EHU)
Elena Ruiz de Gopegui principal investigator
University of the Basque Country (UPV/EHU)
Ana Maria Garcia de la Fuente principal investigator
University of the Basque Country (UPV/EHU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen matrix and autologous connective tissue graft in people with Gingival Recession, run by Elena Ruiz de Gopegui Palacios 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Ruiz de Gopegui (0034649547011, helenruizdegopegui@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
millimeters of new attachment (time frame: Change from baseline at following surgery sixth month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03533933, which also lists 28 linked publications.
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 23 Jul 2019.