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Completed

NCT Number: NCT05777811

The Relationship Between Root Coverage Procedures and Buccal Vestibular Depth

In this comparative trial, 50 patients with shallow vestibules and Type 1/2 recessions will be treated with either a vertically coronally advanced flap + connective tissue graft or a free gingival graft. At baseline, 3rd-month, 6th-month, and 12th-month visits, the following parameters will be evaluated: buccal vestibular depth, keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level. Keratinized tissue change, gingival thickness change, root coverage, clinical attachment gain, and complete root coverage will be calculated. The wound healing index, tissue appearance, patient expectations, aesthetics, and dentin hypersensitivity will be assessed at baseline and at the 6th week.

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Key information

Conditions

Shallow Vestibular Depth Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

Buccal vestibule depth was recorded using two different measurement methods. First, the distance between the cementoenamel junction and the deepest point of the vestibule sulcus was measured and recorded as VD1. Then, the distance between the gingival margin and the base of the vestibule sulcus was measured and recorded as VD2.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • full-mouth plaque and bleeding scores <15%
  • the presence of at least one recession type-1/2 recession and at least one recession with recession depth ≥ 2 mm
  • the presence of an identifiable cemento-enamel junction

Exclusion criteria

  • Vestibule depth > 6mm
  • Smoking > 10 cigarettes per day
  • Any contraindications for periodontal surgery
  • Unstable endodontic conditions or presence of any restoration.

Treatment and study plan

Vertically coronally advanced flap combined with connective tissue graft.

Procedure

The exposed root surfaces are planed with Gracey 1-2 curettes. An intrasulcular incision is made with a blade on the buccal aspects of the involved teeth. The incision is extended horizontally to the adjacent papilla. Then, slightly divergent vertical releasing incisions are carried 2 mm beyond the mucogingival junction. A full-thickness flap is raised with a periosteal elevator towards the mucogingival junction. After that, a partial-thickness dissection is carried out in the apical direction to release muscle tension and provide coronal advancement of the flap. The adjacent papillae are de-epithelialized. The connective tissue graft (CTG) is harvested from the lateral palate using the de-epithelialized gingival graft technique. After harvesting, the connective tissue graft is sutured to the recipient bed. Finally, the flap is positioned 2 mm over the cementoenamel junction and sutured with 6-0 polypropylene sutures. No periodontal dressing is applied.

Free gingival graft

Procedure

A partial-thickness flap is elevated (using a blade #15c) with horizontal incisions at the cemento-enamel junction (CEJ) level of the adjacent teeth. Then, two vertical incisions extending to the apical are made from the two ends of the horizontal incision. The epithelium in the framed region is removed with a scalpel, and the underlying connective tissue is exposed. To achieve the best vascularization of the free gingival graft from the recipient site, bed preparation is completed with a split-thickness horizontal incision that joins the vertical incisions in the apical region. The free gingival graft is stabilized using interrupted sutures and a sling suture.

Other names: epithelialized free gingival graft

Primary outcomes

  1. Vestibule depth 2

    Time frame: Baseline

    The distance between the free gingival margin and the most apical point of the vestibul.

  2. Vestibule depth 2

    Time frame: 3rd month

    The distance between the free gingival margin and the most apical point of the vestibul.

  3. Vestibule depth 2

    Time frame: 6th month

    The distance between the free gingival margin and the most apical point of the vestibul.

  4. Vestibule depth 2

    Time frame: 12th month.

    The distance between the free gingival margin and the most apical point of the vestibul.

  5. Vestibule depth 1

    Time frame: Baseline

    The distance between the free semento-enamel junction and the most apical point of the vestibul.

  6. Vestibule depth 1

    Time frame: 3rd month

    The distance between the free semento enamel junction and the most apical point of the vestibul.

  7. Vestibule depth 1

    Time frame: 6th month

    The distance between the free semento-enamel junction and the most apical point of the vestibul.

  8. Vestibule depth 1

    Time frame: 12th month

    The distance between the free semento-enamel junction and the most apical point of the vestibul.

Secondary outcomes

  1. Recession depth (RD)

    Time frame: Baseline

    Measured as the distance from the cementoenamel junction to the gingival margin

  2. Recession depth (RD)

    Time frame: 6th week

    Measured as the distance from the cementoenamel junction to the gingival margin

  3. Recession depth (RD)

    Time frame: 6th month.

    Measured as the distance from the cementoenamel junction to the gingival margin

  4. Recession depth (RD)

    Time frame: 12th month.

    Measured as the distance from the cementoenamel junction to the gingival margin

  5. Probing depth (PD)

    Time frame: Baseline

    Measures as the distance from the apical of gingival sulcus to the gingival margin.

  6. Probing depth (PD)

    Time frame: 6th week

    Measures as the distance from the apical of gingival sulcus to the gingival margin.

  7. Probing depth (PD)

    Time frame: 6th month

    Measures as the distance from the apical of gingival sulcus to the gingival margin.

  8. Probing depth (PD)

    Time frame: 12th month.

    Measures as the distance from the apical of gingival sulcus to the gingival margin.

  9. Clinical attachment level (CAL)

    Time frame: Baseline.

    measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.

  10. Clinical attachment level (CAL)

    Time frame: 6th week

    measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.

  11. Clinical attachment level (CAL)

    Time frame: 6th month

    measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.

  12. Clinical attachment level (CAL)

    Time frame: 12th month.

    measured as the distance from th tip of the probe inserted into the sulcus to de cementoenamel junction.

  13. Keratinized tissue height (KTH)

    Time frame: Baseline.

    measured from the most apical point of the recession at the gingival margin to the mucogingival line.

  14. Keratinized tissue height (KTH)

    Time frame: 6th week

    measured from the most apical point of the recession at the gingival margin to the mucogingival line.

  15. Keratinized tissue height (KTH)

    Time frame: 6th month

    measured from the most apical point of the recession at the gingival margin to the mucogingival line.

  16. Keratinized tissue height (KTH)

    Time frame: 12th month.

    measured from the most apical point of the recession at the gingival margin to the mucogingival line.

  17. Gingival thickness (GT)

    Time frame: Baseline.

    determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.

  18. Gingival thickness (GT)

    Time frame: 6th week.

    determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.

  19. Gingival thickness (GT)

    Time frame: 6th month.

    determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.

  20. Gingival thickness (GT)

    Time frame: 12th month.

    determined 1.5 mm apical to the gingival margin, measured with the caliper accurete to the nearest 0.1 mm.

  21. Wound healing index (WHI)

    Time frame: 2nd week

    Wound healing index (WHI) was recorded two-weeks after surgery. The wound surface was visually inspected and the soft tissue healing was defined as 'uneventful' (score 1), 'slightly disturbed' (score 2) or 'poor' (score 3) based on the presence and severity of the items including patient discomfort, erythema, edema, suppuration and flap dehiscence.

  22. Tissue appearance (TA)

    Time frame: 6th week

    Tissue appearance (TA) was evaluated by asking the patients to score the consistency, contour, color match, keloid formation degree and contiguity of their treated sites at T2. The scores were collected as points, shown in parentheses, by asking the consistency as firm (1p) or spongy (0p); contour as presence (2p) or absence (0p) of knife-edged and scalloped gingival margin; color match as excellent (3p), good (2p), adequate (1p) or unsatisfactory (0p); keloid formation degree as absent (1p) or present (0p); contiguity as the presence (-1p) or absence (0p) of each perceptible incision mark.

  23. Dentine hypersensitivity (DH)

    Time frame: 6th week

    Dentine hypersensitivity (DH) was evaluated with air evaporative stimulus method at baseline and T2. After placement of finger(s) for preserving the nearby teeth, the recession sites were subjected to evaporative stimulus comprised of 1-second air blast from 1 to 3 mm distance by using the air spray at 40-65 psi pressure and 19±50C. After application, the patients were requested to give a score to their DH between 0 (=no pain) and 10 (=extreme pain).

  24. Patient expectations (PE)

    Time frame: 6th week

    Patient expectations (PE) were evaluated by requesting from the patients to rate their treatment results at T2, as satisfactory or not, in terms of appearance, experience and obtained root coverage.

  25. Aesthetics (A)

    Time frame: 6th week

    Aesthetics (A) was evaluated by the patient at T1 by rating its level as excellent, good, fair or poor.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Effect of Different Recession Coverage Approaches on Sites With Shallow Vestibule Depth

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 21, 2023
Registry last updated
Mar 23, 2023

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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