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CompletedNCT05783258Updated Nov 21, 2023

Connective Tissue Graft From Tuberosity Area and L-PRF Associated With Coronally Advanced Flap for Root Coverage

An interventional study of Periodontal surgery with CAF+tSCTG and Periodontal surgery with CAF+L-PRF in Gingival Recession, sponsored by G. d'Annunzio University. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-21.

Sponsored by G. d'Annunzio University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jun 2022, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the present randomized controlled clinical study is to compare the efficacy of subepithelial connective tissue graft harvested from the maxillary retromolar tubeosity area and L-PRF membranes in the treatment of RT1 recessions by coronally advanced flap.

A total of 30 patients will be recruited and randomly assigned to the test group treated with CAF+tSCTG or the control group treated with (CAF+L-PRF). For each experimental site the parameters of gingival recession (GR), pocket depth (PD), clinical attachment level (CAL), keratinized gingiva width (KT) and gingival thickness (GT) will be analyzed at baseline (T0) and at 12 months after the surgical procedure (T1). In addition, was also evaluated the different morbidity of the two surgical techniques, using the VAS scale values recorded in the first 2 weeks following surgery. It was checked the Patient Related Esthetic Score and Dentine hypersensivite reduction.

02

Conditions studied

  • Gingival Recession

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Keywords

  • Root coverage
  • Periodontal plastic surgery
03

In context

Gingival Recession

402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.

This study's enrollment of 30 is close to the median of 30 across 368 interventional studies indexed under Gingival Recession.

Browse Gingival Recession studies →

Lead sponsor

G. d'Annunzio University is the lead sponsor of 62 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Presence of a class RT1 recession;
  • age > 18 years;
  • systemic health conditions that do not affect the periodontium;
  • Non smoker;
  • FMPS and FMBS values \< 20% before the surgical procedure;
  • absence of implants or subgingival restorations in the sites to be treated;
  • presence of adequate tissue distal to the last maxillary molar.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    CAF+tSCTG

    15 sites will be treated.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 harvesting of the epithelial-connective graft will be performed at the level of the maxillary tuberosity. The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones.

    Procedure: Periodontal surgery with CAF+tSCTG

  • Active comparator
    CAF+L-PRF

    15 sites will be treated.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 bone.A partial thickness dissection will be performed in the apical portion of the flap to obtain complete passivation.The L-PRF membranes will be realized centrifuged venous blood collected in two 10-ml sterile tubes at 3000 rpm for 10 minutes and squeezing the fibrin clot. L-PRF membranes will be superimposed to crete a double layer of about 2 mm thickness.The flap will be repositioned coronally suturing the anatomical papillae on the surgical ones.

    Procedure: Periodontal surgery with CAF+L-PRF

Interventions

  • ProcedurePeriodontal surgery with CAF+tSCTG

    Coronally advanced flap and subepithelial connective tissue graft harvested from the maxillary tuberosity area.

  • ProcedurePeriodontal surgery with CAF+L-PRF

    Coronally advanced flap and L-PRF membranes

06

What researchers measure

Primary outcomes

  1. Gingival thickness

    Gingival tissue thickness 2 mm apical to the recession

    Time frame: 12 months

Secondary outcomes

  1. Keratinized tissue height

    Distance between gingival margin and Mucogingival Junction

    Time frame: 12 months

  2. Gingival recession

    Distance from cementoenamel junction and gingival margin

    Time frame: 12 months

  3. Complete root coverage

    Percentage of experimental sites that achieved complete root surface coverage.

    Time frame: 12 months

  4. Clinical attachment level

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

    Time frame: 12 months

  5. Pocket depth

    Distance between gingival margin and bottom of the pocket

    Time frame: 12 months

07

Study locations

1 site
  • Michele Paolantonio
    Pescara, 65121, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05783258
Lead sponsor
G. d'Annunzio University
Responsible party
Michele Paolantonio (Full time professor, G. d'Annunzio University) — Principal investigator
First posted
Mar 24, 2023
Start date
Jun 13, 2022
Primary completion
Oct 29, 2023
Completion
Oct 29, 2023
Last update
Nov 21, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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