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Split-mouth randomized controlled trial comparing inflammatory biomarkers in early healing time of implant placement between Titanium and PEEK healing abutment

Split-mouth randomized controlled trial comparing inflammatory biomarkers in early healing time of implant placement between Titanium and PEEK healing abutment

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20231102001
Enrollment
15
Registered
2023-11-02
Start date
2023-09-18
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Currently, PEEK has been progressively applied in implant dentistry and further research and a greater number of controlled clinical trials on PEEK implant is required to understand the response of peri-implant soft tissue to PEEK material so that it can replace titanium in future. PEEK healing abutment Titanium IL-1beta TNF-alpha IL-6 Inflammatory biomarker Early healing time

Interventions

comparing inflammatory biomarkers in early healing time of implant placement between Titanium and PEEK healing abutment by GCF and PICF collection
Experimental Device
comparing inflammatory biomarkers in early healing time of implant placement between Titanium and PEEK healing abutment

Sponsors

Faculty of Dentistry, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patient aged more than 20 years old. 2. Patient with healthy condition who can undergo oral surgical procedure; ASA Class I or II. 3. Patient whose presence of 1 Left and 1 right posterior edentulous sites in the same jaw (maxilla or mandible) which are planned to replace with 1 dental implant per site. 4. The width, height, and interocclusal space of both edentulous sites are appropriate for inserting healing abutment size diameter 4.0, Height = 5.0-6.0 mm. 5. Teeth at experimental sites were extracted at least 3 months earlier. 6. The bone quantity and quality are adequate at the experimental sites that allow the placement of dental implants. 7. The amount of keratinized gingiva buccolingually is at least 2 mm at the experimental sites.

Exclusion criteria

Exclusion criteria: 1. Smoking not less than 10 cigarettes/day (within past 12 months) 2. Poorly controlled diabetes (HbA1c more than 8) 3. Pregnancy 4. Current use of medications that adversely affect healing (e.g., corticosteroids, chemotherapeutic, immunosuppressant drugs) 5. History of head and neck radiation 6. History of oral or IV bisphosphonate use 7. Psychological, drug, or alcohol abuse patient 8. History of drug allergy to one or more of drugs are as follows: Amoxicillin, Clindamycin, Ibuprofen, Paracetamol, and Chlorhexidine gluconate mouthwash

Design outcomes

Primary

MeasureTime frame
Levels of IL-1beta, TNF-alpha, IL-6 in GCF and PICF between natural tooth, Titanium site, PEEK site At 24,48,72 hours and 7 days after implant placement using a multiplexed bead immunoassay. The results were calculated with Bio-Plex Manager Software, and the cytokine levels were determined as the amount (pg) per site.

Secondary

MeasureTime frame
N/A N/A N/A

Countries

Thailand

Contacts

Public ContactNatcha Ruansai

Faculty of Dentistry, Mahidol University

tinytoey@gmail.com66917935419

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026