Comparison using the patient's own soft tissue vs an animal material to improve the soft tissue around dental implants

Comparison of volumetric changes in the peri-implant mucosa in horizontal defects using connective tissue graft vs acellular dermal matrix: a randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17926701

Enrollment

Registered

2025-10-01

Start date

2025-09-26

Completion date

Unknown

Last updated

2026-06-08

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

Conditions

Peri-implant mucosa horizontal defects Oral Health

Interventions

Participants will be randomly allocated to either: Test group (n= 16): Porcine dermal matrix (NovoMatrix™) intervention Control group (n= 16): Autogenous connective tissue graft A calibrated examiner

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. >18 years old 2. Presence of a single osseointegrated implant with horizontal volumetric deficiency 3. Full-mouth plaque score (FMPS) <25%

Exclusion criteria

Exclusion criteria: 1. Presence of vertical defects 2. Palate thickness 7%) 4. Current chemotherapy or radiotherapy treatment 5. Immunocompromised status 6. Pregnancy or lactation 7. Smoking >10 cigarettes/day 8. Previous bone augmentation in the treatment area 9. Active periodontal disease or local inflammation and/or infection 10. Known hypersensitivity to porcine-derived materials

Design outcomes

Primary

Measure	Time frame
Volumetric augmentation measured using a digital scan at baseline, 3 months, 6 months, and 1 year post-intervention	—

Secondary

Measure	Time frame
1. Keratinized tissue width measured using a graduated periodontal probe and Lugol's solution at baseline, 3 months, 6 months, and 1 year post-intervention 2. Aesthetic outcomes measured using the Pink Esthetic Score (PES) at baseline, 3 months, 6 months, and 1 year post-intervention 3. Patient Reported Outcome Measures (PROMs) including: 3.1. Postoperative pain measured using a Visual Analogue Scale (VAS) at 6 hours post-intervention, twice daily for the first 5 days, followed by once daily until 14 days postoperatively 3.2. The need of rescue medication, measured using a questionnaire twice daily for the first 5 days, followed by once daily until 14 days postoperatively 3.3. Oral health-related quality of life using the Oral Health Impact Profile-14 (OHIP-14) questionnaire at day 7 post-intervention 3.4. Postoperative bleeding measured using a questionnaire at day 7 post-intervention	—

Measure

Time frame

1. Keratinized tissue width measured using a graduated periodontal probe and Lugol's solution at baseline, 3 months, 6 months, and 1 year post-intervention 2. Aesthetic outcomes measured using the Pink Esthetic Score (PES) at baseline, 3 months, 6 months, and 1 year post-intervention 3. Patient Reported Outcome Measures (PROMs) including: 3.1. Postoperative pain measured using a Visual Analogue Scale (VAS) at 6 hours post-intervention, twice daily for the first 5 days, followed by once daily until 14 days postoperatively 3.2. The need of rescue medication, measured using a questionnaire twice daily for the first 5 days, followed by once daily until 14 days postoperatively 3.3. Oral health-related quality of life using the Oral Health Impact Profile-14 (OHIP-14) questionnaire at day 7 post-intervention 3.4. Postoperative bleeding measured using a questionnaire at day 7 post-intervention

—

Countries

Portugal

Contacts

Public ContactMadalena Braga

111654@egasmonizpt.onmicrosoft.com+351 (0)915816644

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 11, 2026