Back to resultsEfficacy of Collagen Sponge Versus Collagen Membrane on Ridge Preservation of Periodontally Compromised Teeth
Primary Purpose
Periodontitis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
alveolar ridge preservation
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Need for molar extraction due to periodontal disease and plan for late implantation
- No acute infection, such as abscess or effusion
- Presence of bone defects on at one or two socket walls, where the height of the horizontal (suprabony) component of the defect (alveolar bone crest - cement-enamel junction) is >50% of the corresponding root length and the bone height of socket walls is at least 3 mm
- Presence of one adjacent tooth to the extraction site
Exclusion Criteria:
- Smoking
- Pregnancy or lactation
- Untreated periodontal disease
- Severe systemic conditions that contraindicate surgery (such as diabetes, heart disease, cancer etc.)
- Under radiotherapy
- Systemic disease or medication that influences bone metabolism and mucosal healing (such as immunosuppressants, phenytoin, bisphosphonates etc.)
- Extraction of multiple adjacent teeth
- Allergy to any of the materials used in the study
Sites / Locations
- The Affiliated Stomatology Hospital of Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Collagen Membrane
Collagen Sponge
Arm Description
ridge preservation with collagen membrane + collagenated bovine bone mineral
ridge preservation with collagen sponge + collagenated bovine bone mineral
Outcomes
Primary Outcome Measures
change from baseline horizontal width of ridge at 6 months
horizontal width of ridge at 1, 3, 5mm below crest
change from baseline vertical height of ridge at 6 months
vertical height of ridge at the buccal and palatal/lingual plates
Secondary Outcome Measures
width of keratinized tissue
measured from the MGJ to the mucosa margin at the mid-buccal aspect using a periodontal probe
thickness of mucosa
measured at the mid-buccal aspect using an endodontic file with a rubber stop
postoperative pain
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Full Information
NCT ID
NCT05188196
First Posted
December 27, 2021
Last Updated
September 14, 2023
Sponsor
The Dental Hospital of Zhejiang University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05188196
Brief Title
Efficacy of Collagen Sponge Versus Collagen Membrane on Ridge Preservation of Periodontally Compromised Teeth
Official Title
Efficacy of Collagen Sponge Versus Collagen Membrane in Combination With Collagenated Bovine Bone Mineral on Ridge Preservation of Compromised Extraction Sockets in Periodontitis Patients: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Dental Hospital of Zhejiang University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study aims to evaluate the efficacy of ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth.
Detailed Description
The study aims to evaluate the changes of clinical and radiographic outcomes following ridge preservation with collagen sponge or collagen membrane in combination with collagenated bovine bone mineral in extraction sockets of periodontally diseased teeth. The included patients will be randomized into two groups. The patients in control group will be treated with collagen membrane + collagenated bovine bone mineral, and those in the test group will be treated with collagen sponge + collagenated bovine bone mineral. The horizontal width of ridge, the vertical height of ridge at the buccal and palatal/lingual plates, width of keratinized tissue and thickness of mucosa will be measured before surgery and at 6 months postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Collagen Membrane
Arm Type
Active Comparator
Arm Description
ridge preservation with collagen membrane + collagenated bovine bone mineral
Arm Title
Collagen Sponge
Arm Type
Experimental
Arm Description
ridge preservation with collagen sponge + collagenated bovine bone mineral
Intervention Type
Procedure
Intervention Name(s)
alveolar ridge preservation
Intervention Description
Alveolar ridge preservation and augmentation commonly are performed immediately after tooth extraction to preserve or increase ridge volume within or beyond the skeletal envelope that exists at the time of extraction.
Primary Outcome Measure Information:
Title
change from baseline horizontal width of ridge at 6 months
Description
horizontal width of ridge at 1, 3, 5mm below crest
Time Frame
baseline, at 6 months
Title
change from baseline vertical height of ridge at 6 months
Description
vertical height of ridge at the buccal and palatal/lingual plates
Time Frame
baseline, at 6 months
Secondary Outcome Measure Information:
Title
width of keratinized tissue
Description
measured from the MGJ to the mucosa margin at the mid-buccal aspect using a periodontal probe
Time Frame
at 6 months
Title
thickness of mucosa
Description
measured at the mid-buccal aspect using an endodontic file with a rubber stop
Time Frame
at 6 months
Title
postoperative pain
Description
using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)
Time Frame
at 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Need for molar extraction due to periodontal disease and plan for late implantation
No acute infection, such as abscess or effusion
Presence of bone defects on at one or two socket walls, where the height of the horizontal (suprabony) component of the defect (alveolar bone crest - cement-enamel junction) is >50% of the corresponding root length and the bone height of socket walls is at least 3 mm
Presence of one adjacent tooth to the extraction site
Exclusion Criteria:
Smoking
Pregnancy or lactation
Untreated periodontal disease
Severe systemic conditions that contraindicate surgery (such as diabetes, heart disease, cancer etc.)
Under radiotherapy
Systemic disease or medication that influences bone metabolism and mucosal healing (such as immunosuppressants, phenytoin, bisphosphonates etc.)
Extraction of multiple adjacent teeth
Allergy to any of the materials used in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weida Li, master
Phone
0571-87219287
Email
kyb@zjkq.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peihui Ding, Doctor
Organizational Affiliation
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peihui Ding, Doctor
Phone
18957108518
Email
phding@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Collagen Sponge Versus Collagen Membrane on Ridge Preservation of Periodontally Compromised Teeth
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