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NCT Number: NCT05287763

Efficacy of Collagen Sponge on Palatal Wound Healing

The aim of this study is to compare the efficacy of collagen sponge and gelatin sponge on the palatal wound healing and postoperative pain following gingival graft harvesting.

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Key information

Conditions

Gingival Recession Gingival Diseases Inadequately Attached Gingiva Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location status: Recruiting

Location contact

Peihui Ding, Doctor

CONTACT

[email protected]

18957108518

About this study

The aim of this study is to compare the efficacy of collagen sponge and gelatin sponge on the palatal wound healing and postoperative pain following gingival graft harvesting. The included patients will be randomized into two groups. The patients in control group will be treated with gelatin sponge and those in the test group will be treated with collagen sponge. The postoperative pain will be assessed by VAS scale at day 1, 3 and 7 after surgery. Epithelialization of the palatal wound will be evaluated by hydrogen peroxide test and digital photography at 1 week postoperatively. Additionally, postoperative pain, consumption of analgesics, willingness to repeat the treatment and the existence of delayed bleeding will be recorded at 1 week. At 2 weeks, 3 weeks and 1 month after surgery, epithelialization of the palatal wound and aesthetic scores will be evaluated.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Clinical indications utilizing free gingival grafts or de-epithelialized gingival grafts to treat either insufficient keratinized tissue or gingival recession defects
  • Full-mouth plaque score and full-mouth bleeding score lower than 20%

Exclusion criteria

  • Smoking
  • Pregnancy or lactation
  • Untreated periodontal disease
  • Severe systemic conditions that contraindicate surgery (diabetes, heart disease, cancer etc.)
  • Presence of coagulation disorders (history of Haemophilia, von Wille-brand disease, or anticoagulant therapy)
  • Taking medications affecting periodontal health or healing
  • Previous surgery for a palate graft harvested from the experimental sites

Treatment and study plan

Palatal soft tissue graft harvesting

Procedure

After local anaesthesia, a horizontal incision 2 mm apically from the gingival margin will be carried out using a #15C blade. The standardized rectangular graft with a thickness of 1.5 mm will be harvested from distal aspect of canine till first molar. The graft will be lifted and separated using tissue forceps and a blade till it is free from all sides.

Primary outcomes

  1. epithelialization of the palatal wound evaluated by hydrogen peroxide test

    Time frame: at 1 week

    The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).

  2. epithelialization of the palatal wound evaluated by hydrogen peroxide test

    Time frame: at 2 weeks

    The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).

  3. epithelialization of the palatal wound evaluated by hydrogen peroxide test

    Time frame: at 3 weeks

    The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).

  4. epithelialization of the palatal wound evaluated by hydrogen peroxide test

    Time frame: at 1 month

    The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).

  5. epithelialization of the palatal wound evaluated by digital photography

    Time frame: at 1 week

    The epithelialization of the palatal wound will be recorded as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline.

  6. epithelialization of the palatal wound evaluated by digital photography

    Time frame: at 2 weeks

    The epithelialization of the palatal wound will be recorded as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline.

  7. epithelialization of the palatal wound evaluated by digital photography

    Time frame: at 3 weeks

    The epithelialization of the palatal wound will be recorded as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline.

  8. epithelialization of the palatal wound evaluated by digital photography

    Time frame: at 1 month

    The epithelialization of the palatal wound will be recorded as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline.

Secondary outcomes

  1. postoperative pain

    Time frame: at day 1

    using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)

  2. postoperative pain

    Time frame: at day 3

    using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)

  3. postoperative pain

    Time frame: at day 7

    using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)

  4. consumption of analgesics

    Time frame: at 1 week

    to answer the following question: Did you take any analgesics due to the palatal pain since the procedure was completed?

  5. willingness to repeat the treatment

    Time frame: at 1 week

    using a VAS ranging from 0 to 10 (0 = strong unwilling and 10 = strong willing)

  6. the existence of delayed bleeding

    Time frame: at 1 week

    the occurrence of prolonged hemorrhaging during the first week

  7. aesthetic score

    Time frame: at 3 weeks

    assessed by judging on the color, contour, and texture of the donor sites. The total score will vary between 0 and 6 by scoring each subject from 0 to 2 (0=inharmonious with adjacent tissue, 1=moderately harmonious with adjacent tissue and 2=very harmonious with adjacent tissue).

  8. aesthetic score

    Time frame: at 1 month

    assessed by judging on the color, contour, and texture of the donor sites. The total score will vary between 0 and 6 by scoring each subject from 0 to 2 (0=inharmonious with adjacent tissue, 1=moderately harmonious with adjacent tissue and 2=very harmonious with adjacent tissue).

Study contacts

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

Weida Li, master

CONTACT

[email protected]

0571-87219287

Sponsors and collaborators

Lead sponsor

The Dental Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

Efficacy of Collagen Sponge on Palatal Wound Healing: a Randomized Controlled Clinical Trial

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2022
Registry last updated
Aug 7, 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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