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.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorG. d'Annunzio University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Systemic diseases

Coagulation disorders

Medications affecting periodontal status in the previous 6 months

Pregnancy or lactation

Trial design

Design model

Parallel

Treatments tested in this trial

  • CAF+ L-PRF 1 mm

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: CAF+ L-PRF 2 mmExperimental treatment 1 intervention
Group B: CAF+ L-PRF 1 mmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete root coverage

Percentage of experimental sites that achieved complete root surface coverage.

Time frame
6 months

Secondary outcomes

1

Keratinized tissue width

Distance between gingival margin and Mucogingival Junction.

Time frame
6 months
2

Clinical attachment level

Distance between cementoenamel junction(CEJ) and depth of the pocket.

Time frame
6 months
3

Gingival Recession

Distance from cementoenamel junction and gingival margin.

Time frame
6 months
4

Gingival thickness

Gingival tissue thickness evaluated 2 mm apical to the recession.

Time frame
6 months

Other outcomes

Sponsors and contacts

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