Status:
UNKNOWN
Comparison of Clinical and Radiographic Parameters in the Application of Cross-linked Hyaluronic Acid 1.8% and Enamel Matrix Derivative in Periodontal Regeneration.
Lead Sponsor:
University of Valencia
Collaborating Sponsors:
Regedent AG, Zürich
Conditions:
Chronic Periodontitis
Periodontal Bone Loss
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The aim of this study is to compare the effectiveness in periodontal regeneration of cross-linked hyaluronic acid at 1.8% (Hyadent BG®) with enamel matrix derivative (Emdogain®) in periodontal bone de...
Detailed Description
A high molecular weight polysaccharide, hyaluronic acid, also known as hyaluronan or hyaluronate, has recently been studied as a promising mediator for periodontal regeneration. It has a significant r...
Eligibility Criteria
Inclusion
- Periodontitis stage II or III, grade A or B: based on the "Consensus report of workgroup of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions" Tonetti 2017. Clinical attachment loss of 3-5mm, radiographic bone loss to the middle third, loss of teeth ≤4 due to periodontitis, probing depth ≥ 6 mm.
- At least, 20 teeth in the mouth.
- Plaque Index (PI) \< 1, following initial nonsurgical periodontal therapy and hygiene instructions.
- At least one interproximal 2, 3-wall bone defect with moderate to deep intrabony defects (≥3mm) on the radiographs, and clinical probing depths (PD) \>5mm using William's graduated periodontal probe on premolars or molars following initial nonsurgical periodontal therapy.
- Absence of caries or overflowing restorations and periapical injuries of the target tooth.
- Non-smokers.
- Absence of systemic disease.
- Negative history for pregnancy
- No relevant medical history that contraindicate periodontal surgery.
- All participants signed an inform consent form.
- The participant is female or male adult of ≥ 18 years. The sample in sex will be compensated.
- The participant is willing and able to return to the treatments and evaluations programmed throughout this clinical study.
Exclusion
- The participant is pregnant or lactating or plans to become pregnant within the next 6 months.
- Heavy smoker (\>10 cigarettes/day).
- The participant takes\> 4 U of alcohol / day.
- The participant has a chronic illness or decreased mental capacity which would mitigate the ability to comply with the protocol.
- Taking drugs that could alter the participant's response in healing or with oral concomitant manifestations that, in the opinion of the investigator, could interfere with the assessment of safety or efficacy.
- Participants with systemic diseases that interfere with treatment such as, Diabetes mellitus, or rheumatoid arthritis.
- Allergies to drug compounds.
- The participant has been treated with antibiotics within 3 months before starting the study or has any other systemic condition that requires antibiotic coverage for routine periodontal procedures (eg, heart disease, prosthetic joints, etc.).
- Participants should not have received periodontal tretment within the 6-month period prior to study.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04274244
Start Date
March 1 2020
End Date
December 1 2022
Last Update
February 18 2020
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