Gingival RecessionNCT04291963
The Efficacy of De-epithelialized Free Gingival Graft on Treatment of Multiple Gingival Recessions With Tunnel Technique
A study testing DGG + TUN and SCTG + TUN in people with Gingival Recession, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The predictable treatment of multiple adjacent gingival recessions (MAGRs) represents a major challenge in periodontal plastic surgeries due to MAGRs' complicated predisposing anatomic features, such as thin gingival phenotype or limited keratinized tissue. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- DGG + TUN and SCTG + TUN
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Dec 2017to 1 Aug 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Age between 18 - 60 years,
- Non-smoker and systemically healthy,
- No active periodontal disease,
- Presence of at least two single-rooted teeth with Miller class I and/or II (RT1) (Cairo, Nieri, Cincinelli, Mervelt, \& Pagliaro, 2011; Miller, 1985) buccal gingival recession defects ≥2 mm in depth
- Full mouth plaque and bleeding score of <15% and no probing depths >3 mm,
- Absence of non-carious cervical lesions (NCCLs) and non-detectable cemento-enamel junction (CEJ) at the defect sites,
- No history of previous periodontal plastic surgery at the affected sites.
Who cannot join
- • Presence of caries lesions or restorations in the cervical area,
- Intake of medications which impede periodontal tissue health and healing,
- Medical contraindications for periodontal surgical procedures,
- Pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: De-epithelialized Gingival Graft Versus Subepithelial Connective Tissue Graft in the Treatment of Multiple Adjacent Gingival Recessions Using the Tunnel Technique
The predictable treatment of multiple adjacent gingival recessions (MAGRs) represents a major challenge in periodontal plastic surgeries due to MAGRs' complicated predisposing anatomic features, such as thin gingival phenotype or limited keratinized tissue. The present study aimed to investigate the clinical efficacy and postoperative morbidity of de-epithelialized gingival graft (DGG) compared to subepithelial connective tissue graft (SCTG) on the treatment of multiple adjacent gingival recessions (MAGRs) with tunnel technique (TUN). A total of 38 patients, who have been referred to the Gazi University Faculty of Dentistry Department of Periodontology, were randomly assigned to receive TUN in combination with either DGG or SCTG. Clinical measurements were recorded at baseline and at 3, 6 and 12 months after surgeries. Immediately after surgery, a questionnaire was given to each patient evaluating postoperative pain, patients' discomfort, sensitivity and bleeding at 1, 2, 3, 7, 14 and 28 days after surgery. Moreover, the characteristics of the grafts harvested by these two different techniques were evaluated histopathologically and histomorphometrically.
Read the detailed description
The predictable treatment of multiple adjacent gingival recessions (MAGRs) represents a major challenge in periodontal plastic surgeries due to MAGRs' complicated predisposing anatomic features, such as thin gingival phenotype or limited keratinized tissue, variations in the depth and width of the adjacent recession defects, shallow vestibules and high frenum attachments. Furthermore, in these cases, wound healing is often more difficult due to factors such as larger avascular surface and poor blood supply.
The coronally advanced flap (CAF) or the tunnel technique (TUN) with graft-based subepithelial connective tissue procedures have been reported to be the most predictable methods for the treatment of MAGRs. On account of the advantages of TUN, including superior blood supply and advanced wound healing owing to its conservative characteristics associated with the flap elevation without papillae dissection or vertical releasing incisions, this approach has recently achieved popularity compared to other methods.
Although the use of connective tissue grafts (CTGs), together with various surgical techniques, has been accepted as "the gold standart" for the treatment of GRs, some disadvantages of CTG are underlined. Limited donor tissue in the cases where inadequate amount of palatal tissue thickness and/or a bigger dimension of CTG is needed, as in the treatment of MAGRs are claimed to be among those disadvantages (Zucchelli et al., 2010). Moreover, subepitelial CTG (SCTG), either harvested by 'trap-door' (TD) or 'single-incision' (SI) approaches, have been frequently associated with post-operative pain and discomfort, as well as palatal flap necrosis/dehiscence at the donor site.
To overcome these limitations, and obtain a firmer and uniform CTG, de-epithelializing of the free gingival grafts (FGG) have been proposed, especially when palatal fibromucosal tissue thickness is inadequate (≤2.5 mm) and a large graft dimension in apico-coronal or mesio-distal directions is required. De-epithelialized gingival graft (DGG) have also been suggested to have less prone to post-operative shrinkage, because of obtaining larger amount of collagen-rich connective tissue from lamina propria, minimal amount of fatty/glandular tissue and less number of medium to large vessels. Previously it was reported that DGG applied with the TUN presented better manuplation in recipent area and reduced postoperative morbidity compared to a conventional CTG, and resulted in a successful root coverage outcome with increased both width and thickness of the keratinized tissue in the treatment of MAGRs. In a randomized clinical trial (RCT), Zuchelli et al. found no significant differences regarding post-operative pain and root coverage outcomes when compared SCTG and DGG in combination with CAF in the treatment of single or multiple GRs. However, a significant difference was observed in terms of keratinized tissue thickness (KTT) in favor of DGG, and this finding was attributed to the its characteristics of better stability, low shrinkage rates and to allow the incorporation of the portion of connective tissue closest to the epithelium. Despite all biologically advantages of DGG, there is scarce information in the literature on its clinical significance in combination with TUN compared to conventional CTG procedures in the treatment of MAGRs. Therefore, the present study aimed to investigate the clinical efficacy and postoperative morbidity of DGG compared to SCTG on treatment of MAGRs with TUN. The primary objective was to assess the root coverage outcomes of DGG versus SCTG with TUN at 1-year postoperatively. The secondary objectives were to evaluate postoperative patient morbidity of these procedures and the characteristics of the grafts harvested by these two different techniques histopathologically and histomorphometrically.
- Conditions
- Gingival Recession
- Being tested
- DGG + TUN, SCTG + TUN
- Keywords
- gingival recessions, connective tissue graft, de-epithelialized gingival graft, tunnel technique
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DGG + TUNProcedure or surgery
In the DGG group, CTG was obtained at palatal mucosa by means of intra-oral de-epithelialization of the FGG using a 2.3 mm diameter diamond burr (801G/023, EMS, Aldrich Co., USA) with NaCL 0.9% saline irrigation
SCTG + TUNProcedure or surgery
In SCTG group, graft was harvested through the single-incision approach at palatal mucosa
| Study group | Role | What they receive |
|---|---|---|
| DGG + TUN | Active comparator | The multiple adjacent gingival recession sites were treated with DGG in conjunction with TUN technique. Receives: Procedure: DGG + TUN |
| SCTG + TUN | Active comparator | The multiple adjacent gingival recession sites were treated with SCTG in conjunction with TUN technique. Receives: Procedure: SCTG + TUN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root coverage outcomes
Mean root coverage of DGG versus SCTG with TUN
Measured: 1-year postoperatively
Secondary outcomes (6)
Root coverage outcomes
Complete root coverage of DGG versus SCTG with TUN
Measured: 1-year postoperatively
Root coverage outcomes
Recession depth
Measured: 1-year postoperatively
patient morbidity
postoperative pain
Measured: up to 28 days postoperatively
patient morbidity
patients' discomfort
Measured: up to 28 days postoperatively
histopathological features of the graft
graft cellularity
Measured: through study completion, an average of 1 year
histopathological features of the graft
vascularization
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start9 Dec 2017
- Primary completion1 Jun 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sıla Çağrı İşler, Gazi University
- Investigators
- Burcu C Ozdemir, Assoc Prof, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291963
- Sponsor's protocol ID
- 36290600/110
- Status last verified
- Feb 2020
- First submitted
- 24 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aroca S, Barbieri A, Clementini M, Renouard F, de Sanctis M. Treatment of class III multiple gingival recessions: Prognostic factors for achieving a complete root coverage. J Clin Periodontol. 2018 Jul;45(7):861-868. doi: 10.1111/jcpe.12923. Epub 2018 Jun 15.
PubMed 29757468Sculean A, Cosgarea R, Stahli A, Katsaros C, Arweiler NB, Miron RJ, Deppe H. Treatment of multiple adjacent maxillary Miller Class I, II, and III gingival recessions with the modified coronally advanced tunnel, enamel matrix derivative, and subepithelial connective tissue graft: A report of 12 cases. Quintessence Int. 2016;47(8):653-9. doi: 10.3290/j.qi.a36562.
PubMed 27446995Tatakis DN, Chambrone L, Allen EP, Langer B, McGuire MK, Richardson CR, Zabalegui I, Zadeh HH. Periodontal soft tissue root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S52-5. doi: 10.1902/jop.2015.140376. Epub 2014 Oct 15.
PubMed 25315018Tavelli L, Barootchi S, Nguyen TVN, Tattan M, Ravida A, Wang HL. Efficacy of tunnel technique in the treatment of localized and multiple gingival recessions: A systematic review and meta-analysis. J Periodontol. 2018 Sep;89(9):1075-1090. doi: 10.1002/JPER.18-0066. Epub 2018 Aug 13.
PubMed 29761502Aroca 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 23627374Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.
PubMed 25644302Buti 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 23346965Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.
PubMed 20590963Harris RJ. A comparison of two techniques for obtaining a connective tissue graft from the palate. Int J Periodontics Restorative Dent. 1997 Jun;17(3):260-71.
PubMed 9497718Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.
PubMed 7928129Hurzeler MB, Weng D. A single-incision technique to harvest subepithelial connective tissue grafts from the palate. Int J Periodontics Restorative Dent. 1999 Jun;19(3):279-87.
PubMed 10635174Lorenzana ER, Allen EP. The single-incision palatal harvest technique: a strategy for esthetics and patient comfort. Int J Periodontics Restorative Dent. 2000 Jun;20(3):297-305.
PubMed 11203571Griffin 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 17209793Gobbato L, Nart J, Bressan E, Mazzocco F, Paniz G, Lops D. Patient morbidity and root coverage outcomes after the application of a subepithelial connective tissue graft in combination with a coronally advanced flap or via a tunneling technique: a randomized controlled clinical trial. Clin Oral Investig. 2016 Nov;20(8):2191-2202. doi: 10.1007/s00784-016-1721-7. Epub 2016 Jan 27.
PubMed 26814715Isler SC, Eraydin N, Akkale H, Ozdemir B. Oral flurbiprofen spray for mucosal graft harvesting at the palatal area: A randomized placebo-controlled study. J Periodontol. 2018 Oct;89(10):1174-1183. doi: 10.1002/JPER.17-0381. Epub 2018 Aug 29.
PubMed 30007054
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-epithelialized Gingival Graft Versus Subepithelial Connective Tissue Graft in the Treatment of Multiple Adjacent Gingival Recessions Using the Tunnel Technique
- ClinicalTrials.gov ID
- NCT04291963
- Acronym / sponsor ID
- 36290600/110
- Conditions
- Gingival Recession
- Keywords
- gingival recessions, connective tissue graft, de-epithelialized gingival graft, tunnel technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 9 Dec 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 2 Mar 2020 (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.
The predictable treatment of multiple adjacent gingival recessions (MAGRs) represents a major challenge in periodontal plastic surgeries due to MAGRs' complicated predisposing anatomic features, such as thin gingival phenotype or limited keratinized tissue. The present study aimed to investigate the clinical efficacy and postoperative morbidity of de-epithelialized gingival graft (DGG) compared to subepithelial connective tissue graft (SCTG) on the treatment of multiple adjacent gingival recessions (MAGRs) with tunnel technique (TUN). A total of 38 patients, who have been referred to the Gazi University Faculty of Dentistry Department of Periodontology, were randomly assigned to receive TUN in combination with either DGG or SCTG. Clinical measurements were recorded at baseline and at 3, 6 and 12 months after surgeries. Immediately after surgery, a questionnaire was given to each patient evaluating postoperative pain, patients' discomfort, sensitivity and bleeding at 1, 2, 3, 7, 14 and 28 days after surgery. Moreover, the characteristics of the grafts harvested by these two different techniques were evaluated histopathologically and histomorphometrically.
Detailed description
The predictable treatment of multiple adjacent gingival recessions (MAGRs) represents a major challenge in periodontal plastic surgeries due to MAGRs' complicated predisposing anatomic features, such as thin gingival phenotype or limited keratinized tissue, variations in the depth and width of the adjacent recession defects, shallow vestibules and high frenum attachments. Furthermore, in these cases, wound healing is often more difficult due to factors such as larger avascular surface and poor blood supply.
The coronally advanced flap (CAF) or the tunnel technique (TUN) with graft-based subepithelial connective tissue procedures have been reported to be the most predictable methods for the treatment of MAGRs. On account of the advantages of TUN, including superior blood supply and advanced wound healing owing to its conservative characteristics associated with the flap elevation without papillae dissection or vertical releasing incisions, this approach has recently achieved popularity compared to other methods.
Although the use of connective tissue grafts (CTGs), together with various surgical techniques, has been accepted as "the gold standart" for the treatment of GRs, some disadvantages of CTG are underlined. Limited donor tissue in the cases where inadequate amount of palatal tissue thickness and/or a bigger dimension of CTG is needed, as in the treatment of MAGRs are claimed to be among those disadvantages (Zucchelli et al., 2010). Moreover, subepitelial CTG (SCTG), either harvested by 'trap-door' (TD) or 'single-incision' (SI) approaches, have been frequently associated with post-operative pain and discomfort, as well as palatal flap necrosis/dehiscence at the donor site.
To overcome these limitations, and obtain a firmer and uniform CTG, de-epithelializing of the free gingival grafts (FGG) have been proposed, especially when palatal fibromucosal tissue thickness is inadequate (≤2.5 mm) and a large graft dimension in apico-coronal or mesio-distal directions is required. De-epithelialized gingival graft (DGG) have also been suggested to have less prone to post-operative shrinkage, because of obtaining larger amount of collagen-rich connective tissue from lamina propria, minimal amount of fatty/glandular tissue and less number of medium to large vessels. Previously it was reported that DGG applied with the TUN presented better manuplation in recipent area and reduced postoperative morbidity compared to a conventional CTG, and resulted in a successful root coverage outcome with increased both width and thickness of the keratinized tissue in the treatment of MAGRs. In a randomized clinical trial (RCT), Zuchelli et al. found no significant differences regarding post-operative pain and root coverage outcomes when compared SCTG and DGG in combination with CAF in the treatment of single or multiple GRs. However, a significant difference was observed in terms of keratinized tissue thickness (KTT) in favor of DGG, and this finding was attributed to the its characteristics of better stability, low shrinkage rates and to allow the incorporation of the portion of connective tissue closest to the epithelium. Despite all biologically advantages of DGG, there is scarce information in the literature on its clinical significance in combination with TUN compared to conventional CTG procedures in the treatment of MAGRs. Therefore, the present study aimed to investigate the clinical efficacy and postoperative morbidity of DGG compared to SCTG on treatment of MAGRs with TUN. The primary objective was to assess the root coverage outcomes of DGG versus SCTG with TUN at 1-year postoperatively. The secondary objectives were to evaluate postoperative patient morbidity of these procedures and the characteristics of the grafts harvested by these two different techniques histopathologically and histomorphometrically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DGG + TUN | Active comparator | Procedure: DGG + TUNThe multiple adjacent gingival recession sites were treated with DGG in conjunction with TUN technique. |
| SCTG + TUN | Active comparator | Procedure: SCTG + TUNThe multiple adjacent gingival recession sites were treated with SCTG in conjunction with TUN technique. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Age between 18 - 60 years,
Key exclusion criteria (4 listed)
- • Presence of caries lesions or restorations in the cervical area,
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 |
|---|---|---|
| DGG + TUNIn the DGG group, CTG was obtained at palatal mucosa by means of intra-oral de-epithelialization of the FGG using a 2.3 mm diameter diamond burr (801G/023, EMS, Aldrich Co., USA) with NaCL 0.9% saline irrigation | Procedure or surgery | DGG + TUN |
| SCTG + TUNIn SCTG group, graft was harvested through the single-incision approach at palatal mucosa | Procedure or surgery | SCTG + TUN |
Primary outcome
Root coverage outcomes
Time frame: 1-year postoperatively
Mean root coverage of DGG versus SCTG with TUN
6 secondary outcomes
Root coverage outcomes
Time frame: 1-year postoperatively
Root coverage outcomes
Time frame: 1-year postoperatively
patient morbidity
Time frame: up to 28 days postoperatively
patient morbidity
Time frame: up to 28 days postoperatively
histopathological features of the graft
Time frame: through study completion, an average of 1 year
histopathological features of the graft
Time frame: through study completion, an average of 1 year
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 2 Mar 2020.
- Results publication: PubMed 29757468Aroca S, Barbieri A, Clementini M, Renouard F, de Sanctis M. Treatment of class III multiple gingival recessions: Prognostic factors for achieving a complete root coverage. J Clin Periodontol. 2018 Jul;45(7):861-868. doi: 10.1111/jcpe.12923. Epub 2018 Jun 15.
- Results publication: PubMed 27446995Sculean A, Cosgarea R, Stahli A, Katsaros C, Arweiler NB, Miron RJ, Deppe H. Treatment of multiple adjacent maxillary Miller Class I, II, and III gingival recessions with the modified coronally advanced tunnel, enamel matrix derivative, and subepithelial connective tissue graft: A report of 12 cases. Quintessence Int. 2016;47(8):653-9. doi: 10.3290/j.qi.a36562.
- Results publication: PubMed 25315018Tatakis DN, Chambrone L, Allen EP, Langer B, McGuire MK, Richardson CR, Zabalegui I, Zadeh HH. Periodontal soft tissue root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S52-5. doi: 10.1902/jop.2015.140376. Epub 2014 Oct 15.
- Results publication: PubMed 29761502Tavelli L, Barootchi S, Nguyen TVN, Tattan M, Ravida A, Wang HL. Efficacy of tunnel technique in the treatment of localized and multiple gingival recessions: A systematic review and meta-analysis. J Periodontol. 2018 Sep;89(9):1075-1090. doi: 10.1002/JPER.18-0066. Epub 2018 Aug 13.
- Results publication: PubMed 23627374Aroca 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.
- Results publication: PubMed 25644302Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.
- Results publication: 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.
- Results publication: PubMed 20590963Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.
- Results publication: PubMed 9497718Harris RJ. A comparison of two techniques for obtaining a connective tissue graft from the palate. Int J Periodontics Restorative Dent. 1997 Jun;17(3):260-71.
- Results publication: PubMed 7928129Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.
- Results publication: PubMed 10635174Hurzeler MB, Weng D. A single-incision technique to harvest subepithelial connective tissue grafts from the palate. Int J Periodontics Restorative Dent. 1999 Jun;19(3):279-87.
- Results publication: PubMed 11203571Lorenzana ER, Allen EP. The single-incision palatal harvest technique: a strategy for esthetics and patient comfort. Int J Periodontics Restorative Dent. 2000 Jun;20(3):297-305.
- Individual participant dataSharing planned: No
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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.
Burcu C Ozdemir, Assoc Prof study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DGG + TUN and SCTG + TUN in people with Gingival Recession, run by Gazi University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 2 Mar 2020. 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 Turkey (Türkiye). 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?
Root coverage outcomes (time frame: 1-year postoperatively). 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 NCT04291963, which also lists 23 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 2 Mar 2020.