K05.3
Conditions
Interventions
Group 1: During periodontal surgery on the study tooth, one test group receives the collagen matrix in combination with platelet-rich fibrin (PRF for short), which is obtained from the test subjects'
these usually last 10 minutes.
Group 2: The second test group receives the collagen matrix in combination with hyaluronic acid during the periodontal surgery (Visit 2) on the study tooth.
There are a
Sponsors
Universitätsklinikum Bonn
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Minimum age of 18 years Completed anti-infective, non-surgical periodontitis therapy (completed at least 3 months ago) Generally healthy state of health At least one tooth with a vertical bone defect and residual probing depth of = 6 mm Presence of adequate oral hygiene after determination of the FMPI "Full mouth plaque index" Periodontal regenerative measures should be desired Willingness to participate in the study and the necessary follow-up examinations
Exclusion criteria
Exclusion criteria: 17 years or younger Pregnant patients or those planning a pregnancy Existing contraindication for oral surgery Presence of uncontrolled diabetes mellitus or other uncontrolled systemic disease Taking medication with a high dose of steroids Existing bone disease Patients with radiotherapy or immunosuppression Existing infection or vascular compromise at the surgical site Treatment with antibiotics or anti-inflammatory medication (>3 times/week) in the last 3 months Presence of oral lesions (ulcerations, malignant changes, lichen planus) Existing / previously existing malignant diseases of the oral cavity Inadequate oral hygiene Smoking > 10 cigarettes per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visit 7 is to be specified as the endpoint; this is the last follow-up appointment 12 months after the operation. Visit 1: Preoperative examination, review of the inclusion and exclusion criteria, enquiry of the dental history, evaluation of the tooth with intraosseous Pre-operative examination, review of the inclusion and exclusion criteria, enquiry of the dental history, evaluation of the tooth with intrabony defect, completion of the "Oral Health Impact Profile" (OHIP), a questionnaire on oral health and quality of life with regard to oral aspects, assessment of the "Full Mouth Plaque Index" (FMPI) with subsequent oral hygiene instruction, photo documentation and assessment of clinical parameters as part of an attachment status, dental X-ray film of the study tooth (if no current image is available) Visit 2: Periodontal surgery with another prior evaluation of the study tooth, oral hygiene instruction, photo documentation, pain evaluation using a questionnaire Visit 3: First check-up 1 week after surgery (+/- 3 days), pain evaluation using a questionnaire, assessment of wound healing using the Early Wound Healing Index according to Wachtel et al., OHIP questionnaire, recording of adverse events and review of general medication Visit 4: Second check-up 2 weeks after the operation (+/- 3 days) Suture removal in the absence of fibrin, pain evaluation, assessment of wound healing using the Early Wound Healing Index according to Wachtel et al., OHIP sheet, photo documentation, recording of adverse events and review of general medication Visit 5: Third check-up 3 weeks after the operation (+/- 3 days) Suture removal if not performed at visit 4, pain evaluation, assessment of wound healing using the Early Wound Healing Index according to Wachtel et al., OHIP sheet, photo documentation, recording of adverse events and review of general medication Visit 6: Fourth check-up 6 months after surgery (+/- 2 weeks) Evaluation of the tooth with intrabony defect, pain evaluation, | — |
Countries
Germany
Contacts
Public ContactRaluca Cosgarea
Universitätsklinikum Bonn
Outcome results
None listed