Efficacy of Collagen Sponge on Palatal Wound Healing
Primary Purpose
Gingival Recession, Inadequately Attached Gingiva
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Palatal soft tissue graft harvesting
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
Eligibility Criteria
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
Sites / Locations
- The Affiliated Stomatology Hospital of Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Gelatin Sponge
Collagen Sponge
Arm Description
The palatal wound will be protected with an absorbable gelatin sponge, which will be stabilized by non-resorbable sling sutures.
The palatal wound will be protected with a collagen sponge, which will be stabilized by non-resorbable sling sutures.
Outcomes
Primary Outcome Measures
epithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
epithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
epithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
epithelialization of the palatal wound evaluated by hydrogen peroxide test
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
epithelialization of the palatal wound evaluated by digital photography
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.
epithelialization of the palatal wound evaluated by digital photography
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.
epithelialization of the palatal wound evaluated by digital photography
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.
epithelialization of the palatal wound evaluated by digital photography
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 Outcome Measures
postoperative pain
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
postoperative pain
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
postoperative pain
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
consumption of analgesics
to answer the following question: Did you take any analgesics due to the palatal pain since the procedure was completed?
willingness to repeat the treatment
using a VAS ranging from 0 to 10 (0 = strong unwilling and 10 = strong willing)
the existence of delayed bleeding
the occurrence of prolonged hemorrhaging during the first week
aesthetic score
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).
aesthetic score
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).
Full Information
NCT ID
NCT05287763
First Posted
February 28, 2022
Last Updated
September 14, 2023
Sponsor
The Dental Hospital of Zhejiang University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05287763
Brief Title
Efficacy of Collagen Sponge on Palatal Wound Healing
Official Title
Efficacy of Collagen Sponge on Palatal Wound Healing: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Dental Hospital of Zhejiang University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Inadequately Attached Gingiva
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gelatin Sponge
Arm Type
Active Comparator
Arm Description
The palatal wound will be protected with an absorbable gelatin sponge, which will be stabilized by non-resorbable sling sutures.
Arm Title
Collagen Sponge
Arm Type
Experimental
Arm Description
The palatal wound will be protected with a collagen sponge, which will be stabilized by non-resorbable sling sutures.
Intervention Type
Procedure
Intervention Name(s)
Palatal soft tissue graft harvesting
Intervention Description
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 Outcome Measure Information:
Title
epithelialization of the palatal wound evaluated by hydrogen peroxide test
Description
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
Time Frame
at 1 week
Title
epithelialization of the palatal wound evaluated by hydrogen peroxide test
Description
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
Time Frame
at 2 weeks
Title
epithelialization of the palatal wound evaluated by hydrogen peroxide test
Description
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
Time Frame
at 3 weeks
Title
epithelialization of the palatal wound evaluated by hydrogen peroxide test
Description
The appearance of bubbles means the wound is not completely epithelialized. The result will be recorded as a dichotomous variable (yes/no).
Time Frame
at 1 month
Title
epithelialization of the palatal wound evaluated by digital photography
Description
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.
Time Frame
at 1 week
Title
epithelialization of the palatal wound evaluated by digital photography
Description
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.
Time Frame
at 2 weeks
Title
epithelialization of the palatal wound evaluated by digital photography
Description
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.
Time Frame
at 3 weeks
Title
epithelialization of the palatal wound evaluated by digital photography
Description
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.
Time Frame
at 1 month
Secondary Outcome Measure Information:
Title
postoperative pain
Description
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Time Frame
at day 1
Title
postoperative pain
Description
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Time Frame
at day 3
Title
postoperative pain
Description
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Time Frame
at day 7
Title
consumption of analgesics
Description
to answer the following question: Did you take any analgesics due to the palatal pain since the procedure was completed?
Time Frame
at 1 week
Title
willingness to repeat the treatment
Description
using a VAS ranging from 0 to 10 (0 = strong unwilling and 10 = strong willing)
Time Frame
at 1 week
Title
the existence of delayed bleeding
Description
the occurrence of prolonged hemorrhaging during the first week
Time Frame
at 1 week
Title
aesthetic score
Description
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).
Time Frame
at 3 weeks
Title
aesthetic score
Description
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).
Time Frame
at 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weida Li, master
Phone
0571-87219287
Email
kyb@zjkq.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peihui Ding, Doctor
Organizational Affiliation
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peihui Ding, Doctor
Phone
18957108518
Email
phding@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of Collagen Sponge on Palatal Wound Healing
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