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Evaluation of a Xenogeneic Collagen Matrix for the Treatment of Gingival Recession

Evaluation of a Xenogeneic Collagen Matrix for the Treatment of Gingival Recession

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122151
Enrollment
Unknown
Registered
2026-04-09
Start date
2026-04-10
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Gingival Recession

Interventions

control group:Coronally advanced flap surgery + autogenous subepithelial connective tissue graft
experimental group:Coronally advanced flap surgery + VCMX

Sponsors

Peking University Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.The patient has good compliance and oral hygiene status (full-mouth plaque index = 25% after initial therapy). Age > 18 years old and < 60 years old. 2.There is at least one tooth in the anterior and premolar regions with Grade 1 gingival recession (RT1) caused by non-inflammatory factors, such as traumatic brushing habits, stable period after orthodontic treatment, etc. The depth of gingival recession is = 2mm, accompanied by irritation sensitivity symptoms or aesthetic concerns. 3.The cementoenamel junction (CEJ) can be clearly identified, or there are distinct margins of restorations/fillings. 4.The width of keratinized gingiva apical to the gingival recession is = 1mm.

Exclusion criteria

Exclusion criteria: 1. Poorly controlled systemic diseases (e.g., diabetes mellitus with glycosylated hemoglobin > 7%; hypertension with uncontrolled blood pressure = 160/100 mmHg; ischemic heart disease with unstable angina or myocardial infarction symptoms within 30 days; cardiac arrhythmia such as high-degree atrioventricular block; symptomatic heart failure; infective endocarditis, valvular heart disease, etc.); 2. Smoking. 3. Pregnant or lactating women. 4. Poor oral hygiene control with full-mouth plaque score (FMPS) > 20%. 5. Presence of uncorrected harmful brushing habits that may cause gingival trauma. 6. Untreated periodontitis. 7. Significant malocclusion, crowding, displacement, or overeruption of teeth. 8. Previous periodontal plastic surgery at the target tooth sites. 9. Taking medications that may affect mucosal healing or stimulate gingival hyperplasia (e.g., steroids, calcium channel blockers, antiepileptic drugs, immunological antagonists, etc.). 10. History of head and neck radiotherapy or chemotherapy. 11. Long-term residence in other places or frequent business trips, resulting in inability to return for follow-up visits on schedule.

Design outcomes

Primary

MeasureTime frame
mean root coverage, MRC;

Secondary

MeasureTime frame
keratinized gingiva width, KGW;VAS (Visual Analogue Scale) for aesthetic satisfaction;complete root coverage, CRC;clinical attachment level, CAL;VAS (Visual Analogue Scale) for edema, bleeding, and pain at 1 week postoperatively;recession depth, RD;probing depth, PD;Postoperative Mean Root Coverage Area and Gingival Contour Changes:;recession width, RW;Gingival Thickness Changes;

Countries

China

Contacts

Public ContactYang Gang

Peking University Hospital of Stomatology

yanggang@pkuss.bjmu.edu.cn+86 10 82195368

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026