Gingival RecessionNCT05287763
Efficacy of Collagen Sponge on Palatal Wound Healing
A study testing Palatal soft tissue graft harvesting in people with Gingival Recession and Inadequately Attached Gingiva, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gingival Recession, Inadequately Attached Gingiva
- What is being tested?
- Palatal soft tissue graft harvesting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2022to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Peihui Ding, Doctor, 18957108518, phding@zju.edu.cn
About this study
Official title: Efficacy of Collagen Sponge on Palatal Wound Healing: a Randomized Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Gingival Recession, Inadequately Attached Gingiva
- Being tested
- Palatal soft tissue graft harvesting
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palatal soft tissue graft harvestingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Gelatin Sponge | Active comparator | The palatal wound will be protected with an absorbable gelatin sponge, which will be stabilized by non-resorbable sling sutures. Receives: Procedure: Palatal soft tissue graft harvesting |
| Collagen Sponge | Experimental | The palatal wound will be protected with a collagen sponge, which will be stabilized by non-resorbable sling sutures. Receives: Procedure: Palatal soft tissue graft harvesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 1 week
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).
Measured: at 2 weeks
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).
Measured: at 3 weeks
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).
Measured: at 1 month
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.
Measured: at 1 week
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.
Measured: at 2 weeks
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.
Measured: at 3 weeks
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.
Measured: at 1 month
Secondary outcomes (8)
postoperative pain
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Measured: at day 1
postoperative pain
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Measured: at day 3
postoperative pain
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Measured: at day 7
consumption of analgesics
to answer the following question: Did you take any analgesics due to the palatal pain since the procedure was completed?
Measured: at 1 week
willingness to repeat the treatment
using a VAS ranging from 0 to 10 (0 = strong unwilling and 10 = strong willing)
Measured: at 1 week
the existence of delayed bleeding
the occurrence of prolonged hemorrhaging during the first week
Measured: at 1 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).
Measured: at 3 weeks
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).
Measured: at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start30 Apr 2022
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peihui Ding, The Dental Hospital of Zhejiang University School of Medicine
- Investigators
- Peihui Ding, Doctor, Principal investigator, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287763
- Sponsor's protocol ID
- DHZhejiangU-2022(024)
- Status last verified
- Aug 2024
- First submitted
- 28 Feb 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Collagen Sponge on Palatal Wound Healing: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05287763
- Acronym / sponsor ID
- DHZhejiangU-2022(024)
- Conditions
- Gingival Recession, Inadequately Attached Gingiva
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gelatin Sponge | Active comparator | Procedure: Palatal soft tissue graft harvestingThe palatal wound will be protected with an absorbable gelatin sponge, which will be stabilized by non-resorbable sling sutures. |
| Collagen Sponge | Experimental | Procedure: Palatal soft tissue graft harvestingThe palatal wound will be protected with a collagen sponge, which will be stabilized by non-resorbable sling sutures. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palatal soft tissue graft harvestingAfter 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. | Procedure or surgery | Collagen Sponge, Gelatin Sponge |
Primary outcome
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).
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).
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).
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).
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.
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.
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.
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.
8 secondary outcomes
postoperative pain
Time frame: at day 1
postoperative pain
Time frame: at day 3
postoperative pain
Time frame: at day 7
consumption of analgesics
Time frame: at 1 week
willingness to repeat the treatment
Time frame: at 1 week
the existence of delayed bleeding
Time frame: at 1 week
aesthetic score
Time frame: at 3 weeks
aesthetic score
Time frame: at 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peihui Ding, Doctor principal investigator
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palatal soft tissue graft harvesting in people with Gingival Recession and Inadequately Attached Gingiva, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weida Li, master (0571-87219287, kyb@zjkq.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epithelialization of the palatal wound evaluated by hydrogen peroxide test (time frame: at 1 week). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.