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Completed

NCT Number: NCT04690140

Can Modified Coronally Advanced Tunnel be an Alternative in Gingival Phenotype Modification?

In the randomized comparative controlled trial, 50 patients with insufficient keratinized tissue at the anterior mandible were treated with either Modified coronally advanced tunnel or epithelialized free gingival graft. At baseline, 6th week, 6th month, 12th-month visits; keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were evaluated. Keratinized tissue change, Gingival thickness change, root coverage, clinical attachment gain, and complete root coverage were calculated. Wound healing index, tissue appearance, patient expectations, aesthetics, and dentine hypersensitivity were assessed at baseline and 6th week.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • presence of at least two anterior mandibular teeth with keratinized tissue height≤1 mm with gingival thickness ≤1mm
  • presence of at least two recession type-1 recessions at mandibular anterior teeth and at least one recession with recession depth ≥2 mm,
  • aged between 18-60.

Exclusion criteria

  • unstable endodontic conditions or presence of any restoration/abrasion,
  • tooth mobility, any surgical history or gingival enlargement in the area,
  • smoking or alcohol use,
  • uncontrolled systemic disease, pregnancy or use of drugs known to affect gingival conditions

Treatment and study plan

Epithelialized free gingival graft

Procedure

The Epithelialized free gingival graft placed on the prepared bed.

Modified coronally advanced tunnel technique

Procedure

Connective tissue graft placed under the prepared tunnel

Primary outcomes

  1. Gingival Thickness

    Time frame: Baseline

    GT, measured at the midpoint location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).

  2. Gingival Thickness (GT)

    Time frame: 6th week

    GT, measured at the mid-point location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).

  3. Gingival Thickness (GT)

    Time frame: 6th month

    GT, measured at the mid-point location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).

  4. Gingival Thickness (GT)

    Time frame: 12th month

    GT, measured at the mid-point location between the gingival margin and mucogingival junction, using an endodontic spreader (#25 endodontic spreader, 25 mm; D-perfect, Shenzhen, China).

  5. Keratinized Tissue Height (KTH)

    Time frame: Baseline

    KTH, measured from gingival margin to the mucogingival junction (MGJ).

  6. Keratinized Tissue Height (KTH)

    Time frame: 6th week

    KTH, measured from gingival margin to the mucogingival junction (MGJ).

  7. Keratinized Tissue Height (KTH)

    Time frame: 6th month

    KTH, measured from gingival margin to the mucogingival junction (MGJ).

  8. Keratinized Tissue Height (KTH)

    Time frame: 12th month.

    KTH, measured from gingival margin to the mucogingival junction (MGJ).

Secondary outcomes

  1. Recession Depth (RD)

    Time frame: Baseline

    RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.

  2. Recession Depth (RD)

    Time frame: 6th week

    RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.

  3. Recession Depth (RD)

    Time frame: 6th month

    RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.

  4. Recession Depth (RD)

    Time frame: 12th month.

    RD, measured from the cemento-enamel junction (CEJ) to the most apical extension of the gingival margin.

  5. Recession width (RW)

    Time frame: Baseline

    Recession width (RW), the distance between the mesial gingival margin and the distal gingival margin of the tooth measured from the widest point of the recession.

  6. Recession width (RW)

    Time frame: 6th week

    Recession width (RW), the distance between the mesial gingival margin and the distal gingival margin of the tooth measured from the widest point of the recession.

  7. Recession width (RW)

    Time frame: 6th month

    Recession width (RW), the distance between the mesial gingival margin and the distal gingival margin of the tooth measured from the widest point of the recession.

  8. Recession width (RW)

    Time frame: 12th month.

    Recession width (RW), the distance between the mesial gingival margin and the distal gingival margin of the tooth measured from the widest point of the recession.

  9. Probing pocket depth (PD)

    Time frame: Baseline

    Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.

  10. Probing pocket depth (PD)

    Time frame: 6th week

    Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.

  11. Probing pocket depth (PD)

    Time frame: 6th month

    Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.

  12. Probing pocket depth (PD)

    Time frame: 12th month.

    Probing pocket depth (PD), measured from the gingival margin to the bottom of the gingival sulcus.

  13. Clinical attachment level (CAL)

    Time frame: Baseline

    Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.

  14. Clinical attachment level (CAL)

    Time frame: 6th week

    Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.

  15. Clinical attachment level (CAL)

    Time frame: 6th month

    Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.

  16. Clinical attachment level (CAL)

    Time frame: 12th month

    Clinical attachment level (CAL), measured from the cementoenamel junction to the bottom of the gingival sulcus.

  17. Keratinized tissue change (KTC)

    Time frame: Baseline

    Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.

  18. Keratinized tissue change (KTC)

    Time frame: 6th week

    Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.

  19. Keratinized tissue change (KTC)

    Time frame: 6th month

    Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.

  20. Keratinized tissue change (KTC)

    Time frame: 12th month

    Keratinized tissue change (KTC), GT change (GTC), root coverage, clinical attachment gain (CAG) were calculated in millimeters and percentages.

  21. Wound healing index (WHI)

    Time frame: 6th 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

Can Modified Coronally Advanced Tunnel be an Alternative to Epithelialized Free Gingival Graft Technique in Gingival Phenotype Modification? A Comparative Controlled Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 30, 2020
Registry last updated
Mar 6, 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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