Tunnel vs. CAF for the Treatment of Multiple Gingival Recessions
NCT ID: NCT05122468
Last Updated: 2022-11-04
Study Results
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Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2016-12-02
2022-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Follow-up of individual patients will be 6 months (to be extended to 3 years to observe differences in a long-term basis)
TREATMENT
TRIPLE
Study Groups
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CAF group
Coronally advanced flap in combination with a connective tissue graft.
According to the technique(Zucchelli \& De Sanctis 2000), this procedure consists of a rotated papilla, envelope flap. Intrasulcular incisions will be performed involving all the experimental units and at least one tooth mesial and distal to the experimental teeth. From the centre of rotation the incisions will be traced in a corono-apical direction toward the mesial and toward the distal extension of the flap.
After the accurate initial incisions, the flap will be raised full thickness apical to the mucogingival junction (MGJ), exposing 1 to 2 mm of bone at the base of the recession/dehiscence defects.
A linear mesio-distal incision will then be performed to cut the periosteum, releasing any muscular tension and allow a passive coronal positioning of the flap to cover the CEJ.
Connective tissue Harvest and CAF
A connective tissue graft will be harvested from the palate as a free gingival graft, which will be de-epithelialized with a 15-c blade(Zucchelli et al. 2010) before opening of the opaque envelopes, which contains the allocation concealment. The dimensions of the graft achieve 3 to 5 mm mesial and distal from the lateral teeth with an ideal thickness about 1 to 1.5 mm. Donor tissue will be taken at premolar and molar level. In control sites, the graft will be adapted to cover each exposed root to the CEJ, and stabilized with either 6-0 resorbable sutures (with the knot placed under the papillary area) or a non-resorbable suture with the knot on the palatal side. For suturing of the graft, interrupted sutures or sling sutures (anchored to periosteum apical to the graft and hanging around the neck of the experimental teeth) may be used.
Tunnel group
Tunnel technique in combination with a connective tissue graft.
When tunnelling procedures are applied, this technique consists of a supra-periosteal bed under a pedicle flap without any external incisions (Zabalegui et al. 1999). Afterwards, a connective tissue graft is placed and secured through the tunnel, covering the adjacent exposed roots.
To create a tunnel at the buccal aspect of the gingiva, sulcular partial-thickness incisions are made by means of a micro-blade through each recession area, extending the split-thickness beyond the mucogingival junction (MGJ). The partial dissection plane is then extended laterally through the papillae between the treated teeth without separating them. This incision must also be extended 3 to 5 mm mesial and distal from the lateral teeth to allow space for the connective tissue graft.
Connective tissue Harvest and Tunnel
A connective tissue graft will be harvested from the palate as a free gingival graft, which will be de-epithelialized with a 15-c blade(Zucchelli et al. 2010) before opening of the opaque envelopes, which contains the allocation concealment. The dimensions of the graft achieve 3 to 5 mm mesial and distal from the lateral teeth with an ideal thickness about 1 to 1.5 mm. Donor tissue will be taken at premolar and molar level.
In test sites, the graft should be slid through the tunnel. To accomplish the adequate position of the graft into the tunnel, 2 sutures are first placed, 1 at the most mesial and the other at the most distal aspect of the tunnel. The needles should pass underneath the tunnel and exit through the largest or most central gingival recession, the one through which the grafting tissue will be introduced. With these 2 sutures already inside the tunnel, the graft is bitten on both ends with vertical mattress sutures.
Interventions
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Connective tissue Harvest and CAF
A connective tissue graft will be harvested from the palate as a free gingival graft, which will be de-epithelialized with a 15-c blade(Zucchelli et al. 2010) before opening of the opaque envelopes, which contains the allocation concealment. The dimensions of the graft achieve 3 to 5 mm mesial and distal from the lateral teeth with an ideal thickness about 1 to 1.5 mm. Donor tissue will be taken at premolar and molar level. In control sites, the graft will be adapted to cover each exposed root to the CEJ, and stabilized with either 6-0 resorbable sutures (with the knot placed under the papillary area) or a non-resorbable suture with the knot on the palatal side. For suturing of the graft, interrupted sutures or sling sutures (anchored to periosteum apical to the graft and hanging around the neck of the experimental teeth) may be used.
Connective tissue Harvest and Tunnel
A connective tissue graft will be harvested from the palate as a free gingival graft, which will be de-epithelialized with a 15-c blade(Zucchelli et al. 2010) before opening of the opaque envelopes, which contains the allocation concealment. The dimensions of the graft achieve 3 to 5 mm mesial and distal from the lateral teeth with an ideal thickness about 1 to 1.5 mm. Donor tissue will be taken at premolar and molar level.
In test sites, the graft should be slid through the tunnel. To accomplish the adequate position of the graft into the tunnel, 2 sutures are first placed, 1 at the most mesial and the other at the most distal aspect of the tunnel. The needles should pass underneath the tunnel and exit through the largest or most central gingival recession, the one through which the grafting tissue will be introduced. With these 2 sutures already inside the tunnel, the graft is bitten on both ends with vertical mattress sutures.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Persistence of uncorrected gingival trauma from tooth brushing
* Interdental attachment loss greater than 1 mm or furcation involvement in the teeth to be treated
* Presence of severe tooth malposition, rotation or clinically significant super-eruption
* Self-reported current smoking
* Presence of medical contraindications to elective surgery
18 Years
70 Years
ALL
Yes
Sponsors
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Universidad Complutense de Madrid
OTHER
Responsible Party
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Jerian González-Febles
Principal investigator
Principal Investigators
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Mariano Sanz, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Complutense de Madrid
Locations
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Universidad Complutense de Madrid
Madrid, , Spain
Countries
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References
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Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.
Dastoor SF, Travan S, Neiva RF, Rayburn LA, Giannobile WV, Wang HL. Effect of adjunctive systemic azithromycin with periodontal surgery in the treatment of chronic periodontitis in smokers: a pilot study. J Periodontol. 2007 Oct;78(10):1887-96. doi: 10.1902/jop.2007.070072.
Gobbato 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.
Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182.
Rebele SF, Zuhr O, Schneider D, Jung RE, Hurzeler MB. Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivative for root coverage: a RCT using 3D digital measuring methods. Part II. Volumetric studies on healing dynamics and gingival dimensions. J Clin Periodontol. 2014 Jun;41(6):593-603. doi: 10.1111/jcpe.12254.
Zabalegui I, Sicilia A, Cambra J, Gil J, Sanz M. Treatment of multiple adjacent gingival recessions with the tunnel subepithelial connective tissue graft: a clinical report. Int J Periodontics Restorative Dent. 1999 Apr;19(2):199-206.
Zucchelli G, De Sanctis M. Long-term outcome following treatment of multiple Miller class I and II recession defects in esthetic areas of the mouth. J Periodontol. 2005 Dec;76(12):2286-92. doi: 10.1902/jop.2005.76.12.2286.
Zucchelli G, De Sanctis M. Treatment of multiple recession-type defects in patients with esthetic demands. J Periodontol. 2000 Sep;71(9):1506-14. doi: 10.1902/jop.2000.71.9.1506.
Zucchelli G, Mounssif I, Mazzotti C, Stefanini M, Marzadori M, Petracci E, Montebugnoli L. Coronally advanced flap with and without connective tissue graft for the treatment of multiple gingival recessions: a comparative short- and long-term controlled randomized clinical trial. J Clin Periodontol. 2014 Apr;41(4):396-403. doi: 10.1111/jcpe.12224. Epub 2014 Jan 22.
Zucchelli 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.
Zuhr O, Rebele SF, Schneider D, Jung RE, Hurzeler MB. Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivative for root coverage: a RCT using 3D digital measuring methods. Part I. Clinical and patient-centred outcomes. J Clin Periodontol. 2014 Jun;41(6):582-92. doi: 10.1111/jcpe.12178. Epub 2013 Nov 10.
Gonzalez-Febles J, Romandini M, Laciar-Oudshoorn F, Noguerol F, Marruganti C, Bujaldon-Daza A, Zabalegui I, Sanz M. Tunnel vs. coronally advanced flap in combination with a connective tissue graft for the treatment of multiple gingival recessions: a multi-center randomized clinical trial. Clin Oral Investig. 2023 Jul;27(7):3627-3638. doi: 10.1007/s00784-023-04975-7. Epub 2023 Mar 29.
Other Identifiers
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C.I. 16/504
Identifier Type: -
Identifier Source: org_study_id
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