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Gingival Graft Surgery and Donor Site Healing: A Randomized Clinical Trial

Surgical techniques for gingival grafting and donor site regeneration strategies: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3vpbtn2
Enrollment
39
Registered
2026-03-25
Start date
2026-03-30
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Gingival Recession Periodontal Diseases

Interventions

This is a randomized controlled clinical trial with a two-arm, parallel, double-blind design, including a total of 39 participants, with 30 participants allocated to Objective 1 (15 participants in th
masking will be performed at the level of both the examiner and the participant, who will be blinded to the intervention received, while the surgical operator will not be blinded due to the nature of
initially, all participants will undergo a preoperative phase including oral hygiene instructions, plaque control, scaling and root planing, followed by reassessment after 15 days, and only participan
individualized acrylic stents will be fabricated prior to surgery to standardize clinical measurements over time
in the surgical procedure at the recipient site, all participants will undergo the coronally advanced flap technique, including oblique interdental incisions, partial- and full-thickness flap elevatio
in the Control Group of Objective 1, a connective tissue graft obtained from the palate using a free gingival graft followed by de-epithelialization with an approximate thickness of 1.5 mm will be use

Sponsors

Faculdade de Odontologia - Universidade Federal de Uberlândia
Lead Sponsor
Universidade Federal de Uberlândia
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age between 18 and 60 years; both sexes; presence of isolated gingival recession = 4 mm, classified as Miller Class I, II, or III or recession type 1 or 2 according to Cairo classification; systemically healthy patients with no contraindications for periodontal surgery; probing depth < 3 mm at the involved sites; selected teeth free of restorations, caries, or non-carious cervical lesions

Exclusion criteria

Exclusion criteria: Smoking more than 10 cigarettes per day; uncontrolled diabetes mellitus; chronic or aggressive periodontitis; use of medications affecting bone metabolism; chronic upper respiratory tract infections; chronic use of anti-inflammatory drugs or antibiotics; bruxism; alcohol abuse or substance dependence; pregnancy or intention to become pregnant within one year; history of radiotherapy in the head and neck region; diseases affecting bone metabolism; extensive membrane rupture during the surgical procedure

Design outcomes

Primary

MeasureTime frame
To evaluate percentage of root coverage; verified by clinical periodontal examination using a calibrated periodontal probe and standardized acrylic stent

Secondary

MeasureTime frame
To evaluate gingival recession height and width; verified by clinical periodontal examination using a calibrated periodontal probe and standardized acrylic stent; measurements in millimeters of recession height and width will be observed over the evaluation periods. To evaluate gingival thickness; verified by transgingival measurement using a Kerr-type endodontic file with a rubber stopper and digital caliper; thickness in millimeters will be observed at baseline, 6 and 12 months. To evaluate tissue revascularization; verified by color Doppler ultrasonography using color pixel density and flow velocity parameters; perfusion and blood flow values will be observed over time. To evaluate width of keratinized mucosa; verified by clinical measurement using a periodontal probe and standardized stent references; gain in millimeters of keratinized mucosa will be observed. To evaluate clinical attachment level; verified by periodontal probing from the cemento-enamel junction to the base of the gingival sulcus; gain in millimeters of clinical attachment will be observed over time. To evaluate esthetic outcome; verified using the root coverage esthetic score; scores ranging from 0 to 10 will be observed according to standardized criteria. To evaluate postoperative pain; verified using the visual analog scale; scores ranging from 0 to 100 will be observed at 3, 7, 15 and 30 days. To evaluate analgesic consumption; verified through participant self-reported records; the number of doses consumed during the first 7 postoperative days will be observed. To evaluate healing of the recipient site; verified using the Landry healing index; scores ranging from 1 to 5 will be observed at 3, 7 and 15 days

Countries

BR

Contacts

Public ContactPriscilla Soares

Faculdade de Odontologia da Universidade Federal de Uberlândia

pbfsoares@yahoo.com.br+55-34-32258106

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Apr 4, 2026