Clinical trial NCT03791554: Laterally Closed Tunnel VS Tunneling Technique in Recession Type 2
Official title: Clinical Efficacy of Laterally Closed Tunnel With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Subepithelial Connective Tissue Graft in Isolated Recession Type 2; Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: tunneling
laterally closed tunnel
gingival recession
recession type 2
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Its a randomised clinical trial
Primary purpose: TREATMENT

Brief summary: This study aims to assess the effect of tunneling technique with subepithelial connective tissue graft versus tunneling technique with laterally closed tunnel in treatment of recession type 2 defect.Few randomized clinical trial has been involved with recession type 2 defects treated with tunneling technique and coronal advanced flap.

Detailed description: Tunneling with subepithelial connective tissue graft:

At the recipient site (recession defect):

After scaling and root planning. A sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact.

At donor site (palate):

A connective tissue graft is harvested from the palate after administration of local anesthesia using a partial thickness flap which will be raised with single incision.

Then the graft is placed and secured in the recipient site using suture. The flap is displaced to be in a coronal position using a suture.

Tunneling technique with the laterally closed tunnel):

After local anesthesia, root planing of the exposed root surface will be performed. An intrasulcular incisions will be made creating a tunnel extending to the mucogingival line and mesial and distal recession defects while keeping the interdental papilla intact as well as not perforating the flap.

* Donor SCTG Subsequently, a palatal SCTG will be harvested by means of the single incision technique with immediate closure of the donor site.
* Recipient site; Using either single or mattress sutures, the SCTG will be pulled and fixed mesially and distally at the inner aspect of the pouch. The graft will be adapted to the CEJ by means of a sling suture. Finally, the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older.
* Patients with healthy systemic condition
* Buccal recession defects with recession type 2 defects.
* Clinical indication and/or patient request for recession coverage.
* O'Leary index less than 20%

Exclusion Criteria:

* Pregnant females.
* Smokers as it is a contraindication for any plastic periodontal surgery
* Unmotivated, uncooperative patients with poor oral hygiene
* Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.

Primary outcomes:
measure: Reduction Recession Depth
timeFrame: 6 month
Secondary outcomes:
measure: Gingival recession depth.
timeFrame: 6 month
measure: Gingival recession width
timeFrame: 6 month
measure: Root coverage esthetic score (RES)
timeFrame: 6 month
measure: Probing depth
timeFrame: 6 month
measure: Clinical attachment level
timeFrame: 6 month
measure: Width of keratinized tissue
timeFrame: 6 month
measure: Gingival thickness
timeFrame: 6 month
measure: Post-operative pain
timeFrame: 2 weeks
measure: Post-Surgical Patient Satisfaction Questionnaire
timeFrame: 6 month
measure: Percentage complete root coverage
timeFrame: 6 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Almanyal , Cairo
Study officials:
affiliation: Cairo University
name: Manal Hosny, PhD
role: STUDY_CHAIR
affiliation: Cairo University
name: Hani El-Nahass, PhD
role: STUDY_DIRECTOR
References:
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