University of Valencia
Valencia, 46010, Spain
NCT Number: NCT04274244
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Valencia, 46010, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Regenerative periodontal therapy + Cross-linked hyaluronic acid 1.8%:
Other names: REGENERATIVE PERIODONTAL SURGERY (Test group)
Regenerative periodontal therapy + Enamel matrix proteins:
Other names: REGENERATIVE PERIODONTAL SURGERY
Time frame: 1. Baseline, 2. Reevaluation (60 days after root debridement), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
It is defined as the distance in millimeters between CEJ and the end of the periodontal pocket. The calculation of the depth of the pocket + gingival recession or pocket depth - gingival hyperplasia will be carried out.
Time frame: 1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).
Time frame: 1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).
The most coronal position of the alveolar bone crest of the intrabony defect when it touches the root surface of the adjacent tooth before treatment (the top of the crest).
Time frame: 1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).
The most apical extension of the intrabony destruction where the periodontal ligament space still retained its normal width before treatment (the bottom of the defect).
Time frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
The probing depth will be measured in six areas (disto-buccal, mediate-vestibular, mesio-buccal, disto-palatal, mid-palatal, and mesio-palatal) of each tooth with a Williams PQ-OW 208 396 probe. It will be use with a pressure of 20 grams that is equivalent to the pressure of dropping the weight of the probe without exerting additional pressure.
Time frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
The "Full mouth bleeding score" (FMBS) will be calculated based on scores of 0 (no bleeding) or 1 (bleeding) after probing depths are checked. The usual thing is to measure 4 points for each tooth, but we have modified the index and we value 6 points per tooth (disto-buccal, mid-buccal, mesio-buccal, disto-palatal, mid-palatal and mesio-palatal).
We consider that the score is 1 when we see a red dot in the% bleeding diagram of the periodontogram and 0 when we see the blank box.
Time frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
Time frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
The plaque will be quantified as follows:
The evaluation will be carried out in 4 points per tooth (disto-buccal, mesio-buccal, disto-palatal, mesio-palatal).
Time frame: 1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
The plaque will be quantified as follows:
The evaluation will be carried out in 4 points per tooth (disto-buccal, mesio-buccal, disto-palatal, mesio-palatal).
University of Valencia
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03863249
Alveolar Bone Loss, Bone Diseases
Valencia, Spain
View Trial DetailsNCT02218515
Alveolar Bone Loss, Bone Diseases
Istanbul, Şişli/Nişantaşı, Turkey (Türkiye)
View Trial DetailsNCT03241511
Chronic Disease, Chronic Periodontitis
Farmington, Connecticut, United States
View Trial DetailsNCT06254118
Chronic Disease, Chronic Periodontitis
Jeddah, Mecca Region, Saudi Arabia
View Trial Details