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Completed

NCT Number: NCT05494294

Comparison of Different De-epithelialization Techniques of Soft Tissue Grafts.

In this randomized comparative controlled clinical trial, 50 patients with single recession defects with thin phenotype were treated with coronally advanced flap. The connective tissue graft was obtained by removing the keratinized layer of the tissue. Removal of the epithelium was achieved by to different approach. At first group epithelium and remnants were removed extraorally whereas others were intraorally. After the removal, obtained graft laid on a lamella, and residual keratinocytes were observed under the microscope. Amount of recession reduction recorded at the 6th week, 6th month, 12th month, and keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were also 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

Connective Tissue Graft Harvesting

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

  • Single tooth recession more than 2mm
  • Gingival thickness less than 1mm

Exclusion criteria

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

Treatment and study plan

Intraorally de-epithelialization

Procedure

In this group, the grafts were de-epithelialized at the donor site before harvesting. The calibrated surgeon removed the epithelium with a sharp Kirkland knife under magnification. To be sure of the elimination whole epithelial layer, bleeding was observed. Recipient site was prepared as follows; A after sulculer incision had done (blade 15c) two vertical incions were made from the gingival margin to 3 mm beyond the mucogingival junction A partial-thickness flap was elevated under the recession area and full thickness flap elevated adjacent flap portions. then relasing incisions were made apically from the mucogingival junction. After the preparation of the recipient site, obtained graft was sutured 1 mm apically to the cemento-enamel junction. Finally flap was positioned without tension and stabilized at least 2mm coronally from the cemento-enamel margin with the single interrupted sutures.

Extraorally de-epithelialization

Procedure

In this group, the grafts were de-epithelialized after graft harvesting. The calibrated surgeon removed the epithelium with 15 c knife under magnification. all remnants were removed under magnification. Same recipient site procedure was conducted in this group.

Primary outcomes

  1. Recession reduction

    Time frame: 3rd month

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

  2. Recession reduction

    Time frame: 6th month

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

  3. Recession reduction

    Time frame: 12th month

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

Secondary outcomes

  1. amount of deciduous cells

    Time frame: at the day of the surgery.

    Amount of deciduous cells was measured with computerized microscope via histomorfometric methods.

  2. percentage of deciduous cells

    Time frame: at the day of the surgery

    amount of deciduous cells Amount of deciduous cells was measured with computerized microscope via histomorfometric methods.

  3. Recession Depth (RD)

    Time frame: Baseline.

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

  4. Recession Depth (RD)

    Time frame: 3rd month

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

  5. Recession Depth (RD)

    Time frame: 6th month

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

  6. Recession Depth (RD)

    Time frame: 12th month

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

  7. Keratinized Tissue Height (KTH)

    Time frame: baseline

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

  8. Keratinized Tissue Height (KTH)

    Time frame: 3rd month

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

  9. Keratinized Tissue Height (KTH)

    Time frame: 6th month

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

  10. Keratinized Tissue Height (KTH)

    Time frame: 12th month

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

  11. Gingival Thickness (GT)

    Time frame: baseline

    GT, was 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).

  12. Gingival Thickness (GT)

    Time frame: 3rd month

    GT, was 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).

  13. Gingival Thickness (GT)

    Time frame: 6th month

    GT, was 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).

  14. Gingival Thickness (GT)

    Time frame: 12th month

    GT, was 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).

  15. 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.

  16. Recession width (RW)

    Time frame: 3rd 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.

  17. 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.

  18. 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.

  19. Probing pocket depth (PD)

    Time frame: baseline

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

  20. Probing pocket depth (PD)

    Time frame: 3rd month

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

  21. Probing pocket depth (PD)

    Time frame: 6th month

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

  22. Probing pocket depth (PD)

    Time frame: 12th month

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

  23. Clinical attachment level (CAL)

    Time frame: Baseline

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

  24. Clinical attachment level (CAL)

    Time frame: 3rd month

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

  25. Clinical attachment level (CAL)

    Time frame: 6th month

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

  26. Clinical attachment level (CAL)

    Time frame: 12th month

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

  27. Keratinized tissue change (KTC)

    Time frame: 3rd month

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

  28. 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.

  29. 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.

  30. Wound healing index (WHI)

    Time frame: 3rd month

    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.

  31. Wound healing index (WHI)

    Time frame: 6th month

    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.

  32. Wound healing index (WHI)

    Time frame: 12th month

    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.

  33. Tissue appearance (TA)

    Time frame: 3rd month

    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.

  34. Tissue appearance (TA)

    Time frame: 6th month

    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.

  35. Tissue appearance (TA)

    Time frame: 12th month

    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.

  36. Dentine hypersensitivity (DH)

    Time frame: 3rd month

    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).

  37. Dentine hypersensitivity (DH)

    Time frame: 6th month

    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).

  38. Dentine hypersensitivity (DH)

    Time frame: 12th month

    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).

  39. Aesthetics (A)

    Time frame: 3rd month

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

  40. Aesthetics (A)

    Time frame: 6th month

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

  41. Aesthetics (A)

    Time frame: 12th month

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

  42. Vestibuler Depth

    Time frame: baseline

    VD was measured from the gingival margin to the deepest point of to vestibule sulcus.

  43. Vestibuler Depth

    Time frame: 3rd month

    VD was measured from the gingival margin to the deepest point of to vestibule sulcus.

  44. Vestibuler Depth

    Time frame: 6th month

    VD was measured from the gingival margin to the deepest point of to vestibule sulcus.

  45. Vestibuler Depth

    Time frame: 12th month

    VD was measured from the gingival margin to the deepest point of to vestibule sulcus.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Does the De-epithelialization Procedure Affect the Epithelial Remnants and Recession Coverage Outcomes?

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2022
Registry last updated
Aug 11, 2022

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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