Clinical trial NCT06646432: Treatment of Gingival Recession With Tunnel Technique Using Connective Tissue Graft and Injectable Platelet Rich Fibrin
Official title: Treatment of Gingival Recession by Tunnel Technique Using Connective Tissue Graft With or Without Injectable Platelet Rich Fibrin: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession
Keywords: Tunneling
Gingival recession
Injectable platelet rich fibrin
Minimally invasive periodontology
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gingival recession is a common periodontal problem. Consequences include teeth sensitivity, poor esthetics and impaired oral hygiene access. Mild cases are managed by optimizing oral hygiene measures, correction of any causative factor such as faulty tooth brushing, improper dental restoration or denture clasp. Prescription of desensitization products such as specific tooth gels or mouth washes can manage the sensitivity problem. Deeper recession defects need to be addressed by surgical procedures. Coronally advanced flap with connective tissue graft is the gold standard procedure. However, it has some drawbacks due to the need for papillary incisions and vertical incisions in some cases. Within the era of minimally invasive periodontology, tunnel technique with connective tissue graft showed results comparable to coronally advanced flap with connective tissue graft but with some limitations. Addition of another agent may enhance the results of tunnel technique. Injectable platelet rich fibrin is known for its content of growth factors and effects on soft tissue healing. Aim: The study aim is to compare the surgical management of gingival recession with tunnel technique using connective tissue graft and injectable platelet rich fibrin to tunnel with connective graft without injectable platelet rich fibrin.

Methodology: 30 patients with miller class I or II gingival recession will be enrolled. 15 in the test group (Tunnel+ CTG+ i-PRF) and 15 in control group (Tunnel+ CTG). Clinical evaluation at 6 months

Detailed description: 30 patients with miller class I/II gingival recession will be enrolled in this study.

15 patients will be treated using tunnel technique and palatal connective tissue graft inserted and sutured under the prepared tunnel after being soaked in injectable platelet rich fibrin for 15 minutes. The tunnel with the underlying graft will be advanced coronally. (Test Group) The other 15 patients will be treated the same way as in the first group but without soaking the graft in injectable platelet rich fibrin. (Control Group) Clinical parameters will be evaluated at baseline and 6 months follow-up except post-operative pain which will be assessed after 10 days. Histologic examination of small piece of the graft will be done to assess if there is true saturation of growth factors inside the graft.

Eligibility criteria: Inclusion Criteria:

* More than 21 years old
* Systemically healthy
* Presence of Miller class I/II gingival recession
* Presence of identifiable CEJ

Exclusion Criteria:

* Smoking
* Systemic disease that contraindicates surgical procedures.
* Poor compliance with oral hygiene measures
* Necrotizing gingival conditions
* Ongoing active periodontitis

Primary outcomes:
measure: Recession depth
timeFrame: 6 months after the surgery
measure: Keratinized tissue height
timeFrame: 6 months
measure: Gingival thickness
timeFrame: 6 months
Secondary outcomes:
measure: Post operative pain
timeFrame: 10 days
measure: Recession width
timeFrame: 6 months
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Faculty of dentistry, Suez canal university
Study officials:
affiliation: Suez Canal University
name: Abdelnasser Elrefaey
role: STUDY_CHAIR
affiliation: Suez Canal University
name: Shaimaa Morsy
role: STUDY_DIRECTOR
References: