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Clinical Trials in Italy / NCT06701799
Starting soon Not applicable

Clinical Evaluation of Gingival Biotype Changes Using a Coronally Advanced Flap (CAF) in Combination with Leucocyte and Platelet- Rich Fibrin (L-PRF) Membranes of Different Thickness for the Treatment of RT1 Gingival Recession: a Randomized Controlled Clinical Trial.

NCT06701799 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-11-30
Last updated
2024-11-22

Condition(s) studied

Mucogingival DefectsRecession, GingivalGingival Recession, Mucogingival SurgeryL-PRF

Investigational drug(s) / intervention(s)

CAF+ L-PRF 1 mmCAF+ L-PRF 2 mm

CAF+ L-PRF 1 mm: The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm, 2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession.Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa.The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of the crest bone.A partial thickness dissection will be performed in the most apical portion of the flap until complete passivation of the flap is obtained. The L-PRF membrane 1 mm in thickness, will be positioned at the level of the de-epithelialised anatomical papillae.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones, using a Non-Resorbable 5.0 Polyamide Suture.

CAF+ L-PRF 2 mm: The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1 mm, 2 horizontal incisions of approximately 3 mm will be made at the base of the surgical papillae laterally to the recession.Two divergent releasing incisions will be made extending approximately 2-3 mm into the alveolar mucosa.The surgical papillae will be detached in partial thickness. A full thickness dissection will be performed from the bottom of the recession to expose approximately 3mm of the crest bone.A partial thickness dissection will be performed in the most apical portion of the flap until complete passivation of the flap is obtained. The L-PRF membrane 2 mm in thickness, will be positioned at the level of the de-epithelialised anatomical papillae.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones, using a Non-Resorbable 5.0 Polyamide Suture.

Study summary

Gingival thickness plays a key role not only in the etiology but also in the treatment of gingival recessions. More recently, authors reported that as the gingival thickness decreases, the gingival recession severity increases . When gingival inflammation occurs, if the tissue is thin the consequent destruction can quickly produce a gingival recession (GR) .

When treating a gingival recession, the clinician should aim not only to completely cover the exposed root surface but also to prevent a future recession recurrence. The treatment gold standard is the CAF associated with connective tissue graft. This technique has demonstrated high rates in gingival recession reduction and positive predictability in obtaining complete root coverage. However, some disadvantages about this surgical approach can be easily highlighted: patients experience more discomfort, longer chair-time it's necessary and a second wound area is created. In this scenario, The Platelet rich in fibrin and leucocyte (L-PRF) could be a valuable alternative treatment of gingival defects. It's a platelet concentrate, obtained by a fast and simple procedure that does not require anticoagulant and bovine thrombin. It can also be categorized as a live tissue thanks to platelets, leukocytes, growth factors and stem cells trapped in a polymerized fibrin mesh. L- PRF is used in various fields of regenerative medicine; It promotes stabilization and revascularization of the flaps, contributes to soft tissue wound healing and reduces post-operative discomfort. The purpose of this study will be to evaluate if the different thickness of platelet- rich fibrin (L-PRF) membranes in association with a Coronally Advanced Flap (CAF), for the treatment of RT1 gingival recessions, may influence the Complete Root Coverage (CRC).

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Systemic factors (no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation) * Never smokers/former smokers \>=10years * Full-mouth plaque score (FMPS)and a full-mouth bleeding score (FMBS) lower than 15% * No periodontal surgery on the experimental sites * \>= 20 teeth without mobility * No presence of cervical carious lesions or periapical lesions at experimental sites * At least one RT1 buccal gingival recession Exclusion Criteria: * Systemic diseases * Coagulation disorders * Medications affecting periodontal status in the previous 6 months * Pregnancy or lactation * Smokers

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Innovative Technologies in Medicine and Dentistry, Chieti Chieti CH

More G. d'Annunzio University trials in Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06701799 on ClinicalTrials.gov ↗ ← All trials in Italy