Health TrialsbyHealthPanel

Different Suture Diameters in Periodontal Plastic Surgery

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

About this trial

This randomized controlled clinical trial aims to compare the clinical outcomes of using non-resorbable polyamide sutures of different diameters (3.0 vs. 6.0) for securing an advanced coronary flap (CAF) and subepithelial connective tissue graft (SCTG) in the treatment of RT1 gingival recessions (as classified by Cairo et al.).

Forty patients presenting with at least one RT1 recession will be enrolled in the study. Twenty participants will undergo CAF + SCTG sutured with non-resorbable polyamide thread of 3.0 diameter, while the other 20 participants (control group) will receive the same procedure sutured with a 6.0 diameter thread. The primary outcome, complete root coverage (CRC), will be assessed six months after treatment.

Additional clinical parameters, including gingival recession (GR), clinical attachment level (CAL), pocket depth (PD), keratinized tissue width (KT), keratinized tissue thickness (GT), and Root Coverage Esthetic Score (RES), will be evaluated at baseline and at the six-month follow-up.

Patient-reported outcomes (PROs) will also be measured, including the degree of general discomfort (D) experienced, assessed on a Visual Analog Scale (VAS) from 0 to 10, as well as patient-reported aesthetic satisfaction (PRES) and overall treatment satisfaction (OTS), both quantified on a VAS scale from 0 to 10.

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

a 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

  • Suture 3.0 Group

    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 harvesting of the epithelial-connective graft will be performed at the la. 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, using a Non-Resorbable Polyamide Suture of 3.0 Diameter.

  • Suture 6.0 Group

    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 harvesting of the epithelial-connective graft will be performed at the la. 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, using a Non-Resorbable Polyamide Suture of 6.0 Diameter.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Suture 3.0 GroupActive comparator 1 intervention
Group B: Suture 6.0 GroupExperimental 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

Gingival Recession

Distance from cementoenamel junction and gingival margin

Time frame
6 months
2

Gingival thickness

Gingival tissue thickness evaluated 2 mm apical to the recession

Time frame
6 months
3

Keratinized tissue width

Distance between gingival margin and Mucogingival Junction

Time frame
6 months
4

Clinical attachment level

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

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

G. d'Annunzio University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: