Is a new gum replacement material from a pig as effective as a person's own gum taken from the palate placed around dental implants?

Comparison of epithelized connective tissue graft and porcine dermal matrix (mucoderm®) to increase the amount of peri-implant soft tissue. Randomised controlled clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15762095

Enrollment

Registered

2020-01-22

Start date

2018-01-10

Completion date

Unknown

Last updated

2020-02-10

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

Conditions

Peri-implant mucositis, peri-implantitis Oral Health

Interventions

Subjects were divided into control and test groups for both the upper and lower jaws. The total duration of the study is one year. Subject Groups: 1. Upper jaw test gr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who underwent implant surgery restored with dental implant-supported prosthesis, but PIKM is either absent or PIKM-W is less than 2mm 2. Patients prior to implant surgical procedure, but keratinised mucosa was insufficient at the edentulous area

Exclusion criteria

Exclusion criteria: 1. Elective oral surgical intervention is contraindicated. In particular patients with uncontrolled or poorly controlled diabetes should be excluded. 2. Uncontrolled or untreated periodontal disease 3. Smoker 4. Infections or recent surgical procedures within 30 days of study initiation 5. Pregnant or lactating 6. Chronic treatment with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists, cyclosporine) 7. Radiotherapy or chemotherapy in the past 12 months prior to surgery 8. HIV or hepatitis 9. Physical handicaps that would interfere with the ability to perform adequate oral hygiene 10. Any investigational drug within 30 days of study initiation 11. Alcoholism or chronically drug abuse causing systemic compromisation 12. Severe bruxism or clenching habits

Design outcomes

Primary

Measure	Time frame
PIKM width (PIKM-W) in mm, measured at baseline, 1, 3, 6, 9, 12 months	—

Secondary

Measure	Time frame
1. PIKM thickness (PIKM-T) in mm, measured at baseline, 1, 3, 6, 9, 12 months 2. Pocket Probing Depths (PPD) measured at baseline, 3, 6, 9, 12 months 3. Plaque Index (PI) measured at baseline, 1, 3, 6, 9, 12 months 4. Bleeding on Probing (BoP) measured at baseline, 1, 6, 9, 12 months 5. Full mouth plaque score (FMPS) measured at baseline 6. Patient-centred outcomes: 6.1 Postoperative pain measured by VAS at 2 weeks 6.2 Cumulative painkillers taken post-operatively at 2 weeks 6.3 Surgical time	—

Measure

Time frame

1. PIKM thickness (PIKM-T) in mm, measured at baseline, 1, 3, 6, 9, 12 months 2. Pocket Probing Depths (PPD) measured at baseline, 3, 6, 9, 12 months 3. Plaque Index (PI) measured at baseline, 1, 3, 6, 9, 12 months 4. Bleeding on Probing (BoP) measured at baseline, 1, 6, 9, 12 months 5. Full mouth plaque score (FMPS) measured at baseline 6. Patient-centred outcomes: 6.1 Postoperative pain measured by VAS at 2 weeks 6.2 Cumulative painkillers taken post-operatively at 2 weeks 6.3 Surgical time

—

Countries

Hungary

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026