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Clinical and Patient-Reported Outcomes of Collagen Sponge Versus Hyaluronic Acid (1.25%) EZ-Gel in Palatal Donor Site Healing: A Randomized Clinical Trial

Clinical and Patient-Reported Outcomes of Collagen Sponge Versus Hyaluronic Acid (1.25%) EZ-Gel in Palatal Donor Site Healing: A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202605741161720
Enrollment
60
Registered
2026-05-14
Start date
2026-02-28
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Health

Interventions

Hyaluronic acid

Sponsors

safinaz saleh
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: systemically healthy adults r Between 18 and 60 years of age adequate palatal tissue thickness (= 2.5 mm) at the donor site. All participants should demonstrate good oral hygiene

Exclusion criteria

Exclusion criteria: medications that may interfere with normal tissue repair, including systemic corticosteroids, immunosuppressive agents, or anticoagulant therapy, Pregnant or lactating women, heavy smokers (> 5 cigarettes per day), patients with a history of hypersensitivity to collagen or hyaluronic acid presence of active infection, inflammation, or pathological lesions at the palatal donor site, any previous surgical intervention at the same donor site within the preceding six months.

Design outcomes

Primary

MeasureTime frame
Wound size reduction: Wound size will be measured at baseline immediately after graft harvesting and at subsequent follow-up visits using standardized photographs and image analysis software or calibrated periodontal probing. ;Color match and tissue texture: The quality of healed palatal mucosa will be evaluated based on color match and surface texture compared with adjacent healthy tissue using a standardized clinical scoring system. This parameter will reflect tissue maturation and integration. ;Time to complete epithelialization: Time to complete epithelialization will be defined as the number of days required for total surface coverage of the donor site with no exposed connective tissue. This outcome will be determined clinically and confirmed photographically at follow-up visits.

Secondary

MeasureTime frame
1. Postoperative pain intensity: Pain intensity will be assessed using a Visual Analog Scale (VAS), with 0 indicating no pain and 10 indicating the worst imaginable pain. Patients will record pain levels daily during the first postoperative week. ;Discomfort during mastication and speech: Functional discomfort during chewing and speaking will be evaluated using a VAS or structured questionnaire. This parameter will reflect the functional impact of the palatal wound. Assessment will be performed at ;Burning sensation or local irritation: Burning or irritation at the donor site will be recorded using a VAS to assess wound sensitivity and tissue response to the applied dressing. ;4. Patient satisfaction: Overall patient satisfaction with healing and comfort will be evaluated using a numerical rating scale or questionnaire.

Countries

Egypt

Contacts

Public Contactahmed mohamed elghayesh

lecturer

ahmed.elghayesh@dent.tanta.edu.eg01066860969

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026