Clinical trial NCT04274244: Comparison of Clinical and Radiographic Parameters in the Application of Cross-linked Hyaluronic Acid 1.8% and Enamel Matrix Derivative in Periodontal Regeneration.
Official title: Comparison of Clinical and Radiographic Parameters in the Application of Cross-linked Hyaluronic Acid 1.8% (Hyadent BG®) and Enamel Matrix Derivative (Emdogain®) in Periodontal Regeneration: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Periodontitis
Periodontal Bone Loss
Keywords: Periodontitis
Hyaluronic acid
Periodontal regeneration
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Regedent AG, Zürich
First posted: 2020-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 defects evaluating their clinical and radiographic variables.

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 role in mineralized and non-mineralized periodontal tissues for the functioning of its extracellular matrices. It has a multifunctional role in periodontics including the stimulation of cell migration, proliferation and differentiation and the acceleration of wound healing by stimulating angiogenesis. It is used in surgical procedures due to its osteoinductive potential. HA is a key element in soft periodontal tissues, the gingiva and periodontal ligament, and in hard tissue, such as alveolar bone and cementum. It has many structural and physiological functions within these tissues.

This research proposes two experimental groups to whom one of them will be applied cross-linked hyaluronic acid at 1.8% and another group with enamel matrix derivative, and a control group.

The investigator's hypothesis is that the hyaluronic acid shows potential for periodontal regeneration when evaluating its clinical and radiographic variables and when compared with the use of Enamel matrix derivative.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. At least, 20 teeth in the mouth.
3. Plaque Index (PI) \< 1, following initial nonsurgical periodontal therapy and hygiene instructions.
4. 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.
5. Absence of caries or overflowing restorations and periapical injuries of the target tooth.
6. Non-smokers.
7. Absence of systemic disease.
8. Negative history for pregnancy
9. No relevant medical history that contraindicate periodontal surgery.
10. All participants signed an inform consent form.
11. The participant is female or male adult of ≥ 18 years. The sample in sex will be compensated.
12. The participant is willing and able to return to the treatments and evaluations programmed throughout this clinical study.

Exclusion Criteria:

1. The participant is pregnant or lactating or plans to become pregnant within the next 6 months.
2. Heavy smoker (\>10 cigarettes/day).
3. The participant takes\> 4 U of alcohol / day.
4. The participant has a chronic illness or decreased mental capacity which would mitigate the ability to comply with the protocol.
5. 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.
6. Participants with systemic diseases that interfere with treatment such as, Diabetes mellitus, or rheumatoid arthritis.
7. Allergies to drug compounds.
8. 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.).
9. Participants should not have received periodontal tretment within the 6-month period prior to study.

Primary outcomes:
measure: Clinical measure: Clinical attachment loss (CAL). Changes will be assessed at 3 time points.
timeFrame: 1. Baseline, 2. Reevaluation (60 days after root debridement), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
Secondary outcomes:
measure: Radiographic measure: Cemento-enamel junction (A1)
timeFrame: 1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).
measure: Radiographic measure: B1
timeFrame: 1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).
measure: Radiographic measure: D1
timeFrame: 1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).
measure: Clinical measure: Probing pocket depth (PPD). Changes will be assessed at 3 time points.
timeFrame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
measure: Clinical measure: Gingival recession (GR). Changes will be assessed at 3 time points.
timeFrame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
measure: Clinical measure: Tooth mobility (TM) Miller (1950). Changes will be assessed at 3 time points.
timeFrame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
measure: Clinical measure: Furcation involvement: Hamp (1975). Changes will be assessed at 3 time points.
timeFrame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
measure: Clinical measure: Plaque Index (Sillness y Löe 1964). Changes will be assessed at 3 time points.
timeFrame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
Other outcomes:
Locations:
Study officials:
affiliation: University of Valencia
name: Andrés López Roldán
role: STUDY_DIRECTOR
affiliation: University of Valencia
name: Manuel Rodríguez Aranda
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Francisco Alpiste Illueca
role: STUDY_DIRECTOR
References: