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?

Not Applicable

• Conditions: Peri-implant mucositis, peri-implantitis; Oral Health

• Registration Number: ISRCTN15762095
• Lead Sponsor: Department of Periodontology, Faculty of Dentistry, Semmelweis University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-22
• Last Update Posted: 10 February 2020
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 48

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PIKM width (PIKM-W) in mm, measured at baseline, 1, 3, 6, 9, 12 months

Secondary Outcome Measures

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