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The goal of this clinical trial is to evaluate gingival recession depth reduction using tunneled coronally advanced flap compared to coronally advanced flap, both combined with connective tissue graft in patients with isolated RT2 gingival recession sites.
Gingival recession can cause clinical conditions that could be of main concern for patients. Techniques aiming for coverage of the gingival recession aim to address dentin hypersensitivity, non-carious cervical lesions (NCCLs) and enhance patient's esthetics (Cortellini & Bissada, 2018). Mid-buccal gingival recessions have been associated with patient's esthetic discomfort (Zucchelli & Mounssif, 2015). Most of the studies in the literature focus on the treatment of RT1 recession as they have the most favorable prognosis of full root coverage (Barootchi et al., 2020). Despite most studies focusing their attention on RT1 cases, RT2 defects are found to be the most prevalent type with 88.8% among patients according to (Romandini et al., 2020).
The coronally advanced flap and the tunneling technique are the most commonly performed surgical approaches for treating gingival recessions. However, these two approaches have commonly been regarded as alternatives to each other, with clinicians choosing to perform only one of them during root coverage procedures.
(Barootchi & Tavelli, 2022) aimed in his conducted case series to designate a surgical technique to treat isolated RT2 gingival recession defects in which he was trying to achieve and combine the advantage of both better access and graft stabilization in CAF and the preservation of the integrity of the papilla and better blood supply to the graft present in tunneling technique. The study concluded that the combination of both techniques in the same surgical design can have the potential to enhance flap and graft vascularization and improve clinical, esthetic, and patient-reported outcomes. To our knowledge, there is no conducted randomized clinical trials comparing the tunneled coronally advanced flap technique to the coronally advanced flap for gingival depth reduction.
So, this clinical trial aims to address this gap of the literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tunneled coronal advanced flap with connective tissue graft | Experimental | TCAF involves the elevation of one trapezoidal surgical papilla at the papilla with less interproximal clinical attachment loss, by a slightly divergent vertical incision extending beyond the mucogingival junction is done then a horizontal incision at a distance equal to the recession depth plus 1 mm apical to the papilla tip just as the conventional coronally advanced flap (CAF). Then a tunneling knife will be used to perform the intra-sulcular incision on the treated site and on the tooth adjacent to the papilla that will be preserved for tension-free flap advancement. The midfacial aspect of the tooth will be elevated with tunneling knives while the surgical papilla will be elevated in a split-thickness manner. . The anatomical papilla will be de-epithelialized, either with a surgical blade or micro scissors, while the other papilla will be gently mobilized with a tunneling instrument. . The harvested connective tissue graft will be inserted underneath the flap |
|
| Coronally advanced flap with connective tissue graft | Active Comparator | A trapezoidal-shaped flap will be elevated with a split-full-split approach in the coronal-apical direction:
The harvested connective tissue graft will be inserted underneath the flap |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tunneled coronal advanced flap with connective tissue graft | Procedure | Tunneled coronal advanced flap with connective tissue graft to treat isolated RT2 gingival recession sites. |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Recession Depth | It's measured as the distance between cemento-enamel junction (CEJ), and gingival margin (GM) using periodontal probe. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of mean root coverage (MRC%) | (Preoperative vertical recession depth - Postoperative vertical recession/preoperative vertical recession) x 100 [%] | 6 months |
| Percentage of complete root coverage (CRC%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omar H Sallam, MSc | Contact | +201113203236 | omar.sallam@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Engy Ahmed, PhD | Cairo University | Study Chair |
| Omar A Ashour, PhD | Cairo University | Study Chair |
| Yehia H Amer, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35175005 | Result | Barootchi S, Tavelli L. Tunneled coronally advanced flap for the treatment of isolated gingival recessions with deficient papilla. Int J Esthet Dent. 2022 Feb 17;17(1):14-26. |
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I will check with my study chair.
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It's randomized clinical trial
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Single blinded
| Coronally advanced flap with connective tissue graft | Procedure | Coronally advanced flap with connective tissue graft to treat isolated RT2 gingival recession sites |
|
Number of defect sites with complete root coverage/ Total number of recession sites treated x 100 [%]
| 6 months |
| Gingival Recession Width | Measured at the widest point (it is the distance between the mesial gingival margin and the distal gingival margin of the tooth) | 6 months |
| Gingival Thickness | Measured using transgingival needle probing using anesthesic needle a rubber stopper | 6 months |
| Keratinized Tissue Width | Measured as the distance between the gingival margin and the mucogingival junction (MGJ). | 6 months |
| Clinical Attachment Level | Measured from the CEJ to the bottom of the gingival sulcus. | 6 months |
| Probing Pocket Depth | Measured from the gingival margin to the bottom of the gingival sulcus. | 6 months |
| Pink Esthetic Score | It's a score by (Fürhauser et al., 2005) based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable is assessed with a 0-1-2 score, with 2 being the best and 0 being the poorest score. | 6 months |
| Post-operative pain | Visual Analogue Scale (VAS) with numerical scale from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 weeks postoperatively. | 2 weeks |
| Post-operative patient satisfaction | A 3-item questionnaire will be given to the patients to be answered using a 7-point answer scale for assessing their satisfaction with the whole surgical procedure and the achieved results of the procedure performed. | 2 weeks, 6 months |
| Root coverage esthetic score | (Cairo et al., 2009) This score evaluates five variables: level of the gingival margin (GM) , marginal tissue contour (MTC), soft tissue texture (STT) , mucogingival junction (MGJ) alignment , and gingival color (GC).
| 6 months |
| Cairo University |
| Study Chair |
| Omar H Sallam, MSc | Cairo University | Principal Investigator |
| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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