Back to resultsComparison of Clinical and Radiographic Parameters in the Application of Cross-linked Hyaluronic Acid 1.8% and Enamel Matrix Derivative in Periodontal Regeneration.
Primary Purpose
Chronic Periodontitis, Periodontal Bone Loss
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML
Enamel Matrix Proteins (Active comparator group)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Periodontitis, Hyaluronic acid, Periodontal regeneration
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML
Enamel Matrix Proteins
Scale and root planning
Arm Description
The study participants will first undergo SCALE AND ROOT PLANING. This procedure is the same as that used in the active comparator group and the control group. Eight weeks following the initial therapy, reevaluation of the intrabony defects in the interproximal sites with a clinical probing depth >5 mm will be performed by radiographs as well as by using William's graduated periodontal probe to confirm the indication for periodontal surgery. Pairs of premolar and molar teeth in the maxilla or the mandible will be randomized to receive the test treatment (REGENERATIVE PERIODONTAL SURGERY with adjunctive hyaluronic acid gel application) or to serve as active comparators (regenerative periodontal surgery with adjunctive enamel matrix derivative application).
SCALE AND ROOT PLANING REGENERATIVE PERIODONTAL SURGERY: Application of enamel matrix derivative.
Control group: Just SCALE AND ROOT PLANING is performed
Outcomes
Primary Outcome Measures
Clinical measure: Clinical attachment loss (CAL). Changes will be assessed at 3 time points.
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.
Secondary Outcome Measures
Radiographic measure: Cemento-enamel junction (A1)
• The cemento-enamel junction (CEJ)of the tooth involved in the intrabony defect.
Radiographic measure: B1
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).
Radiographic measure: D1
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).
Clinical measure: Probing pocket depth (PPD). Changes will be assessed at 3 time points.
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.
Clinical measure: Gingival recession (GR). Changes will be assessed at 3 time points.
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.
Clinical measure: Tooth mobility (TM) Miller (1950). Changes will be assessed at 3 time points.
Class I: Mobility up to 1 mm in the horizontal direction.
Class II: Mobility greater than 1 mm in the horizontal direction.
Class III: Excessive movement in both horizontal and vertical directions.
Clinical measure: Furcation involvement: Hamp (1975). Changes will be assessed at 3 time points.
The plaque will be quantified as follows:
Score 0 = no plaque
Score 1 = A film of plaque adhered to the free gingival margin and the adjacent area of the tooth. The plaque can be seen in situ only after the application of a plaque revealer or by using the probe on the surface of the tooth.
Score 2 = moderate accumulation of soft deposits in the pocket, tooth or gingival margin, which can be seen with our eyes.
Puntuación 3 = Abundance of soft material inside the bag and / or on the tooth and the gingival margin.
The evaluation will be carried out in 4 points per tooth (disto-buccal, mesio-buccal, disto-palatal, mesio-palatal).
Clinical measure: Plaque Index (Sillness y Löe 1964). Changes will be assessed at 3 time points.
The plaque will be quantified as follows:
Score 0 = no plaque
Score 1 = A film of plaque adhered to the free gingival margin and the adjacent area of the tooth. The plaque can be seen in situ only after the application of a plaque revealer or by using the probe on the surface of the tooth.
Score 2 = moderate accumulation of soft deposits in the pocket, tooth or gingival margin, which can be seen with our eyes.
Puntuación 3 = Abundance of soft material inside the bag and / or on the tooth and the gingival margin.
The evaluation will be carried out in 4 points per tooth (disto-buccal, mesio-buccal, disto-palatal, mesio-palatal).
Full Information
NCT ID
NCT04274244
First Posted
April 9, 2019
Last Updated
February 15, 2020
Sponsor
University of Valencia
Collaborators
Regedent AG, Zürich
1. Study Identification
Unique Protocol Identification Number
NCT04274244
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
Regedent AG, Zürich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Periodontal Bone Loss
Keywords
Periodontitis, Hyaluronic acid, Periodontal regeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blinding: The researchers who performed the measurements will be different from those who performed the surgery; therefore, the examiner will be blinded during the entire duration of the study.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML
Arm Type
Experimental
Arm Description
The study participants will first undergo SCALE AND ROOT PLANING. This procedure is the same as that used in the active comparator group and the control group.
Eight weeks following the initial therapy, reevaluation of the intrabony defects in the interproximal sites with a clinical probing depth >5 mm will be performed by radiographs as well as by using William's graduated periodontal probe to confirm the indication for periodontal surgery. Pairs of premolar and molar teeth in the maxilla or the mandible will be randomized to receive the test treatment (REGENERATIVE PERIODONTAL SURGERY with adjunctive hyaluronic acid gel application) or to serve as active comparators (regenerative periodontal surgery with adjunctive enamel matrix derivative application).
Arm Title
Enamel Matrix Proteins
Arm Type
Active Comparator
Arm Description
SCALE AND ROOT PLANING
REGENERATIVE PERIODONTAL SURGERY: Application of enamel matrix derivative.
Arm Title
Scale and root planning
Arm Type
No Intervention
Arm Description
Control group: Just SCALE AND ROOT PLANING is performed
Intervention Type
Drug
Intervention Name(s)
Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML
Other Intervention Name(s)
REGENERATIVE PERIODONTAL SURGERY (Test group)
Intervention Description
Regenerative periodontal therapy + Cross-linked hyaluronic acid 1.8%:
The modified minimal invasive surgical technique, described by Cortellini 2011, will be used to raise the interdental papilla over the bone defect.
Measurement of bone defect with a 0.5mm periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Illinois, USA) to characterize the defect anatomy.
Inflammatory tissue will be debrided and the root carefully planed using Gracey curettes.
The site will be washed with physiologic sterile solution, dried and the root wil be conditioned with 24% Ethylenediamine tetraacetic acid (EDTA) for two minutes, then the defect area will be carefully rinsed with sterile saline to remove any residual EDTA.
Application of Hyadent BG® 1,8% filling the bone defect from the bottom upwards in the test group.
Single internal modified mattress suture (5/0 Vicryl, Ethicon).
Sutures will be removed after two weeks.
Intervention Type
Drug
Intervention Name(s)
Enamel Matrix Proteins (Active comparator group)
Other Intervention Name(s)
REGENERATIVE PERIODONTAL SURGERY
Intervention Description
Regenerative periodontal therapy + Enamel matrix proteins:
The modified minimal invasive surgical technique, described by Cortellini 2011, will be used to raise the interdental papilla over the bone defect.
Measurement of bone defect with a 0.5mm periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Illinois, USA) to characterize the defect anatomy.
Inflammatory tissue will be debrided and the root carefully planed using Gracey curettes.
The site will be washed with physiologic sterile solution, dried and the root wil be conditioned with 24% Ethylenediamine tetraacetic acid (EDTA) for two minutes, then the defect area will be carefully rinsed with sterile saline to remove any residual EDTA.
Application of Emdogain® filling the bone defect from the bottom upwards in the active comparator group.
Single internal modified mattress suture (5/0 Vicryl, Ethicon).
Sutures will be removed after two weeks.
Primary Outcome Measure Information:
Title
Clinical measure: Clinical attachment loss (CAL). Changes will be assessed at 3 time points.
Description
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. Reevaluation (60 days after root debridement), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
Secondary Outcome Measure Information:
Title
Radiographic measure: Cemento-enamel junction (A1)
Description
• The cemento-enamel junction (CEJ)of the tooth involved in the intrabony defect.
Time Frame
1. Baseline, 2. Second reevaluation (180 days after Periodontal regenerative surgery).
Title
Radiographic measure: B1
Description
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).
Title
Radiographic measure: D1
Description
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. Second reevaluation (180 days after Periodontal regenerative surgery).
Title
Clinical measure: Probing pocket depth (PPD). Changes will be assessed at 3 time points.
Description
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).
Title
Clinical measure: Gingival recession (GR). Changes will be assessed at 3 time points.
Description
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).
Title
Clinical measure: Tooth mobility (TM) Miller (1950). Changes will be assessed at 3 time points.
Description
Class I: Mobility up to 1 mm in the horizontal direction.
Class II: Mobility greater than 1 mm in the horizontal direction.
Class III: Excessive movement in both horizontal and vertical directions.
Time Frame
1. Baseline, 2. Reevaluation (60 days after Scale and root planing), 3. Second reevaluation (180 days after Periodontal regenerative surgery).
Title
Clinical measure: Furcation involvement: Hamp (1975). Changes will be assessed at 3 time points.
Description
The plaque will be quantified as follows:
Score 0 = no plaque
Score 1 = A film of plaque adhered to the free gingival margin and the adjacent area of the tooth. The plaque can be seen in situ only after the application of a plaque revealer or by using the probe on the surface of the tooth.
Score 2 = moderate accumulation of soft deposits in the pocket, tooth or gingival margin, which can be seen with our eyes.
Puntuación 3 = Abundance of soft material inside the bag and / or on the tooth and the gingival margin.
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).
Title
Clinical measure: Plaque Index (Sillness y Löe 1964). Changes will be assessed at 3 time points.
Description
The plaque will be quantified as follows:
Score 0 = no plaque
Score 1 = A film of plaque adhered to the free gingival margin and the adjacent area of the tooth. The plaque can be seen in situ only after the application of a plaque revealer or by using the probe on the surface of the tooth.
Score 2 = moderate accumulation of soft deposits in the pocket, tooth or gingival margin, which can be seen with our eyes.
Puntuación 3 = Abundance of soft material inside the bag and / or on the tooth and the gingival margin.
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Rodríguez Aranda
Phone
+34696902721
Email
m.rodriguezaranda1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrés López Roldán
Organizational Affiliation
University of Valencia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Manuel Rodríguez Aranda
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco Alpiste Illueca
Organizational Affiliation
University of Valencia
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Comparison of Clinical and Radiographic Parameters in the Application of Cross-linked Hyaluronic Acid 1.8% and Enamel Matrix Derivative in Periodontal Regeneration.
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