Skip to content

Clinical and patient-centered outcomes from the palatal donor area submitted to two forms of protection after free gingival graft removal

Clinical and patient-centered outcomes from the palatal donor area submitted to two forms of protection after free gingival graft removal: a randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-69hn7t8
Enrollment
Unknown
Registered
2022-01-07
Start date
2021-11-11
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

palate, hard

Interventions

The palatal donor areas of 44 individuals who will undergo root coverage surgery for gingival recession (GR) anterior mandibular unit will receive two forms of protection. In the ECF group with epithe
E06.892

Sponsors

Faculdade de Odontologia da Universidade Federal de Pelotas
Lead Sponsor
Faculdade de Odontologia da Universidade Federal de Pelotas
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 18 years and over; not having reported systemic diseases; have a healthy periodontal or demonstrate stable periodontal condition after conventional periodontal therapy; have gingival bleeding index and bacterial plaque index less than 15%; have clinical indication for periodontal plastic surgery using connective tissue graft, in order to treat single gingival recession defects, around natural teeth located in the anterior region of the mandible (canine to canine); no history of previous palatal harvest

Exclusion criteria

Exclusion criteria: Pregnancy or infants; report the use of medications that would adversely affect periodontal tissues; have inadequate endodontic treatment; smokers or former smokers who have stopped smoking less than a year ago; possess tooth mobility at the surgery site; possessing the need for orthodontic treatment prior to the completion of root coverage surgery

Design outcomes

Primary

MeasureTime frame
Evaluate the healing of the free gingival graft donor area (epithelialization area) at 7, 14 and 28 days after surgery, comparing the two different protection methods used. For this purpose, standardized photographs will be taken (identical settings of camera and flash), at a specific angle (mirror of 45º placed in relation to the surface of the palate). An acetate plate, with a cutout of the size of the graft area, will be used as a reference. The analyzes will be performed by software (Fiji ImageJ®), and the remaining healing areas of the wounds will be measured, in square millimeters, at the beginning (after removal of the graft) and at 7, 14 and 28 days after surgery.

Secondary

MeasureTime frame
To assess postoperative pain, patients will be instructed to complete a visual analogue scale (VAS) and rate the level of pain experienced at the palate site from 0 to 10, with 10 being the worst pain ever experienced. Each measurement will be taken on days 1, 2, 3, 4, 5, 6, 7, 10 and 14 postoperatively, at the same time every day.;Patients will also answer the following question: How many pain reliever pills were taken in the first 14 days? This variable will be collected on the same days of analysis of the VAS scale (days 1, 2, 3, 4, 5, 6, 7, 10 and 14 postoperatively).;Oral health-related quality of life will be measured using the “Oral Health Impact Profile” (OHIP)-14 questionnaire. This questionnaire consists of 14 questions and is divided into seven domains. The version validated for the Brazilian population will be used. This instrument will be applied at the initial consultation before surgery and after 7, 14 and 28 days.

Countries

Brazil

Contacts

Public ContactLuiz Da Rocha
luizedurocha@gmail.com+552128688282

Outcome results

None listed

Source: REBEC (via WHO ICTRP)