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

Phase 4

Recruiting

• Conditions: healing abutment; Titanium; IL-1beta; TNF-alpha; IL-6; Inflammatory biomarker; Early healing time; PEEK; 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.

• Registration Number: TCTR20231102001
• Lead Sponsor: Faculty of Dentistry, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-02
• Study Completion: 2024-03-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evels 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 Outcome Measures

Name	Time	Method
/A N/A N/A