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Healing of the roof of the mouth after surgery using an intraoral dressing, with or without tissue from the patient

Healing of the palatal wound protected with a self-adhesive intraoral dressing with or without autogenous epithelialized fragments: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8g3q8q6
Enrollment
44
Registered
2026-01-26
Start date
2026-01-02
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Soft palate Wounds and injuries

Interventions

This is a randomized controlled clinical trial with two parallel arms and a single-blind design (outcome assessor blinded), including 44 participants equally allocated into two groups (n = 22 per grou

Sponsors

Universidade Federal de Pelotas
Lead Sponsor
Universidade Federal de Pelotas
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age equal to or greater than eighteen years; Not having any reported systemic diseases, even if controlled; Having a healthy periodontium, defined as probing depth equal to or less than three millimeters, or presenting a stable periodontal condition after conventional periodontal therapy, defined as probing depth equal to or less than four millimeters without bleeding on probing; Having a gingival bleeding index lower than ten percent and a visible plaque index lower than fifteen percent; Having a clinical indication for periodontal plastic surgery with harvesting of an epithelial-connective tissue graft for the treatment of single gingival recessions with a minimum depth of three millimeters, classified as RT1 or RT2, around sound natural teeth located in the maxilla or mandible, except molars; Not having a previous history of palatal graft harvesting; Presenting a minimum palatal thickness between two point five and three millimeters at the donor site, compatible with connective tissue graft harvesting; Being available to attend all clinical visits and home records scheduled in the study.

Exclusion criteria

Exclusion criteria: Pregnancy or lactation; Reporting the use of medications that adversely affect periodontal tissues; Having inadequate endodontic treatment; Being a smoker or former smoker who quit smoking less than one year ago; Having tooth mobility at the surgical site; Having the need for orthodontic treatment prior to root coverage surgery; Being allergic to any of the preoperative or postoperative medications that will be prescribed, including dexamethasone four milligrams, amoxicillin five hundred milligrams, nimesulide one hundred milligrams, dipyrone five hundred milligrams, or chlorhexidine gluconate zero point twelve percent.

Design outcomes

Primary

MeasureTime frame
Postoperative healing level of the palatal donor site, including epithelialization area and residual wound area, assessed at 7, 14, and 28 days after free gingival graft harvesting (free gingival graft), comparing groups with and without repositioning of autogenous epithelial-connective tissue fragments.

Secondary

MeasureTime frame
Postoperative pain perception assessed using the visual analogue scale (VAS) daily from days 1 to 7 and on days 10 and 14; ;Amount of analgesics consumed between days 1 and 7 and on days 10 and 14; ;Occurrence of postoperative complications at the palatal donor site; ;Patient satisfaction assessed through self-perception;;The study includes a new data collection procedure, which consists of applying the Pittsburgh Sleep Quality Index (PSQI), a version validated for Brazilian Portuguese. The scale will be applied on days 0, 7, 14, and 28. The average changes in scores throughout the follow-up periods will be calculated. In addition, the number of individuals with at least poor sleep quality will also be calculated

Countries

BR

Contacts

Public ContactFrancisco Wilker Muniz

Universidade Federal de Pelotas

wilkermustafa@gmail.com+55(53)3222-2766

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Jun 29, 2026