Intrabony Periodontal Defect, Periodontitis, Adult
Conditions
Brief summary
The present investigation is designed in order to compare the radiographic and clinical effectiveness of flapless procedure performed alone or in combination with enamel matrix derivatives in the periodontal regenerative treatment of deep intrabony defects in patients with moderate or severe periodontitis. The study will have a follow-up of 12 months.
Interventions
PROCEDUREFlapless with Enamel Matrix Derivatives (EMD)
Experimental sites will receive a closed non-surgical treatment with a combined use of minicurettes and ultrasonic instruments with thin and delicate tips. Teeth will be instrumented until no residual calculus could be detected. A visualization of the root surface will be accomplished under magnification by using dental loups 4.0X. In the test group, the roots will be conditioned with 24% ethylenediaminetetraacetic acid (EDTA) for 2 minutes. After rinsing with sterile saline, enamel matrix derivatives (EMD) will be applied on the dried root surface.
PROCEDUREFlapless without Enamel Matrix Derivatives (EMD)
Experimental sites will receive a closed non-surgical treatment with a combined use of minicurettes and ultrasonic instruments with thin and delicate tips. Teeth will be instrumented until no residual calculus could be detected. A visualization of the root surface will be accomplished under magnification by using dental loups 4.0X. No adjunct will be administered.
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* diagnosis of periodontitis stage III or IV; * presence of at least one tooth with ≥6 mm associated with a radiographic intrabony defect ≥3 mm at least 2 months after the completion of non-surgical therapy; * a full-mouth plaque score and full-mouth bleeding score \<15% at the time of the experimental procedure; * signed informed consent.
Exclusion criteria
* relevant medical disorders contraindicating periodontal surgery or detrimental to periodontal healing; * consumption of drugs known to affect periodontal status; * pregnancy and lactation; * third molars, teeth with furcation involvement or inadequate endodontic treatment and/or prosthetic restoration; * heavy smokers \>10 cigarettes per day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level change | 12 months | Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic bone level change | 12 months | Periapical standardized radiographs will be taken by a clinician masked to the clinical measurements using the paralleling technique and individually customized bite-blocks (RINN XCP Film Holding Instruments, Dentsply, York, USA) |
| Probing pocket depth change | 12 months | Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA) |
Countries
Italy
Outcome results
None listed