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NCT Number: NCT06701786

Optimizing Clinical Outcomes in CAF + SCTG: the Impact of Compressive Sutures

This randomized controlled clinical trial aims to evaluate the additional effect on clinical outcomes of compressive sutures associated with coronally advanced flap (CAF) and subepithelial connective tissue graft (SCTG) for 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 with compressive sutures while the other 20 participants will receive the same procedure without compressive sutures. 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.

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Key information

Conditions

Gingival Recessions Gingival Diseases Gingival Recession Gingival Recession, Mucogingival Surgery Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases Suture

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Innovative Technologies in Medicine and Dentistry, Chieti,

Chieti, 66100, Italy

Location contact

Michele Paolantonio, MD DDS

CONTACT

[email protected]

Michele Paolantonio, MD, DDS

CONTACT

About this study

The study will be a prospective, randomized, and controlled clinical trial designed to evaluate the added benefit of compressive sutures (2 orizzontal and 1 vertical sutures) on CAF + SCTG to treat RT1 gingival recessions. For each study patient, one RT1 recession will be included. Clinical parameters will be evaluated at baseline and six months after treatment.

Forty patients under care at the Periodontology Unit of the University of Chieti-Pescara, Italy, and presenting RT1 recessions, will be selected for inclusion.

All 40 patients will first undergo professional supragingival scaling using ultrasonic instruments. Patients will also receive motivational oral hygiene instructions to adopt proper, pressure-free brushing techniques and non-traumatic use of dental floss and/or interdental brushes. The use of a pressure-controlled electric toothbrush with an extra-soft head will be recommended, and detailed instructions for its use will be provided. Access to the surgical phase will only be permitted after the achievement of supragingival plaque control through these non-traumatic oral hygiene procedures.

A computer-generated, customized randomization table will be used to allocate experimental units into the two study groups.

Post-surgical care will include a regimen of 2 g/day of amoxicillin combined with clavulanic acid for six days and oral ibuprofen 600 mg as needed for pain control. Sutures will be removed two weeks after surgery. Plaque control of the grafted area will be managed for three weeks post-surgery with a twice-daily rinse using a 0.12% chlorhexidine digluconate solution. Additionally, patients will apply a 1% chlorhexidine gel twice daily. Patients will undergo weekly professional supragingival cleaning and motivational reinforcement sessions for six weeks. Gentle cleaning with a soft toothbrush and interdental cleaning will be allowed starting two weeks after suture removal. All measurements will be performed by a single experienced operator. Complete root coverage (CRC) will be assumed as the main outcome at 6 months after treatment. Gingival recession (GR), clinical attachment level (CAL), pocket depth (PD), keratinized tissue width (KT,) thickness of keratinized tissue (GT), Root coverage esthetic score will be assessed at baseline and 6 months after treatment. PROMs will also be evaluated. The degree of general discomfort (D) experienced will be assessed on a VAS scale (0-10). Patient-reported aesthetic satisfaction (PRES) at T1 will also be quantified on a VAS scale (0-10). Overall treatment satisfaction (OTS) at T1 will be assessed by asking each patient if they would undergo surgery again (yes/no).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • a 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

Treatment and study plan

Compressive Sutures (CSs) group

Procedure

The extent of the depth of the recession will be reported on the anatomical papillae and, after adding 1mm, 2 horizontal incisions of approximately 3mm will be made at the base of the surgical papillae laterally to the recession.Two divergent releasing incisions will be made extending approximately 2-3mm 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 . The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae; then the flap will be repositioned coronally suturing the anatomical papillae on the surgical ones. Three compressive sutures will be placed on the repositioned flap.

Without Compressive Sutures (WCSs) group

Procedure

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. The de-epithelialised graft will be sutured at the level of the de-epithelialised anatomical papillae; than then the flap will be repositioned coronally suturing the anatomical papillae on the surgical ones.

Primary outcomes

  1. Complete root coverage

    Time frame: 6 months

    Percentage of experimental sites that achieved complete root surface coverage.

Secondary outcomes

  1. Gingival Recession

    Time frame: 6 months

    Distance from cementoenamel junction and gingival margin

  2. Gingival thickness

    Time frame: 6 months

    Gingival tissue thickness evaluated 2 mm apical to the recession

  3. Keratinized tissue width

    Time frame: 6 months

    Distance between gingival margin and Mucogingival Junction

  4. Clinical attachment level

    Time frame: 6 months

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

  5. Pocket depth

    Time frame: 6 months

    Distance between gingival margin and bottom of the pocket

  6. Discomfort

    Time frame: 4 weeks

    Evaluation of post-operative discomfort using Visual Analogue Scale (VAS).The scale is represented by a straight horizontal line of fixed length, generally 10 cm. Extremities are defined as extreme limits of the parameter to be measured, oriented from left (worst) to right (best).

  7. Patient-Reported Esthetic Satisfaction

    Time frame: 6 months

    Patient-reported esthetic satisfaction (PRES) quantified on a VAS scale (0-10), will be recorded after observing simultaneously 2 standardized photographs showing the treated site +2 mesial and 2 distal teeth and the MGJ

  8. Root Coverage Esthetic Score

    Time frame: 6 months

    This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color.

Study contacts

Contact information is provided by the study sponsor or research team.

Michele Paolantonio, MD, DDS

CONTACT

[email protected]

3395204073

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

Compressive Sutures Improve Clinical Outcomes in CAF + SCTG for Treatment of RT1 Recessions"

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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