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Comparison between a biomaterial and autogenous graft in the treatment of gingival recessions. Randomized controlled clinical trial

Comparison between porcine acellular dermal matrix and subepithelial connective tissue graft in root coverage of gingival recessions. Randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2ss7yy8
Enrollment
20
Registered
2025-09-17
Start date
2019-06-05
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

gingival recession Biocompatible Materials

Interventions

Controlled, randomized, split-mouth clinical trial with a 24-month follow-up period. The study followed the principles of the Declaration of Helsinki for research involving human participants. Twenty

Sponsors

Universidade de São Paulo
Lead Sponsor
Faculdade de Odontologia de Ribeirao Preto da Universidade de Sao Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Both sexes; minimum age of 18 years; bilateral single gingival recessions affecting homologous maxillary or mandibular non-molar teeth, classified as Miller Class I or II and/or Cairo RT1; recession depth of at least 2 mm at both sites; main complaint of esthetics and/or unresolved dentin hypersensitivity; indication for root coverage surgery; willingness to participate in the study and sign the informed consent form

Exclusion criteria

Exclusion criteria: Systemic diseases or conditions that could interfere with healing or surgical outcomes; contraindication for periodontal surgery; smokers or current tobacco users; alcohol abuse or chronic drug use; active periodontal disease; pregnant or breastfeeding women; previous periodontal surgery at the selected sites; poor oral hygiene, defined as full-mouth plaque score and/or full-mouth bleeding score greater than 20%

Design outcomes

Primary

MeasureTime frame
Primary outcome expected: It was expected that both treatments would reduce gingival recession height after 24 months, with the primary comparison being the between-treatment difference in the change in gingival recession height (?GR, mm) from baseline to 24 months. Gingival recession height was defined as the distance from the cementoenamel junction to the gingival margin and was measured clinically by a calibrated examiner blinded to treatment allocation. ;Primary outcome found: Gingival recession height decreased in both treatment groups after 24 months. At the 24-month follow-up, residual gingival recession height was 0.389 ± 0.116 mm in the porcine acellular dermal matrix group and 0.419 ± 0.116 mm in the subepithelial connective tissue graft group. No significant treatment × time interaction was observed for gingival recession height, indicating a similar clinical pattern between treatments over time.

Secondary

MeasureTime frame
Expected secondary outcome 8: It was expected that both treatments would improve patient satisfaction with root coverage (SRC), assessed by a standardized scale during postoperative follow-up.;Expected secondary outcome 9: It was expected that both treatments would improve patient satisfaction with gingival color (SGC), assessed by a standardized scale during postoperative follow-up.;Secondary outcome found 1: At 24 months, keratinized tissue width remained stable, with values of 1.71 ± 0.24 mm in the porcine acellular dermal matrix group and 1.79 ± 0.24 mm in the subepithelial connective tissue graft group.;Secondary outcome found 2: Gingival thickness increased over time, reaching 1.069 ± 0.09 mm in the porcine acellular dermal matrix group and 1.190 ± 0.09 mm in the subepithelial connective tissue graft group at 24 months.;Secondary outcome found 3: At 24 months, probing depth remained compatible with periodontal health in both treatment groups.;Secondary outcome found 4: At 24 months, clinical attachment level improved in both treatment groups.;Secondary outcome found 5: At 24 months, the percentage of root coverage was 86.6 ± 4.24% in the porcine acellular dermal matrix group and 85.8 ± 4.24% in the subepithelial connective tissue graft group.;Secondary outcome found 6: Complete root coverage was observed in 6/15 sites (40.0%) in the porcine acellular dermal matrix group and in 8/15 sites (53.3%) in the subepithelial connective tissue graft group.;Secondary outcome found 7: Dentin hypersensitivity decreased from 7.40 ± 0.45 to 1.27 ± 0.45 in the porcine acellular dermal matrix group and from 7.20 ± 0.45 to 1.27 ± 0.45 in the subepithelial connective tissue graft group. ;Secondary outcome found 8: Satisfaction with root coverage remained high at 24 months, with scores of 93.3 ± 3.15 in the porcine acellular dermal matrix group and 96.0 ± 3.15 in the subepithelial connective tissue graft group. ;Secondary outcome found 9: Satisfaction with gingival color remai

Countries

BR

Contacts

Public ContactArthur Novaes Junior

Faculdade de Odontologia de Ribeirao Preto da Universidade de Sao Paulo

novaesjr@forp.usp.br+55(16)3315-4788

Outcome results

None listed

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