Efficacy of Collagen Sponge Versus Collagen Membrane on Ridge Preservation of Periodontally Compromised Teeth

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: alveolar ridge preservation

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weida Li, master; Phone Number: 0571-87219287; Email: kyb@zjkq.com.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The Affiliated Stomatology Hospital of Zhejiang University School of Medicine
      • Contact: Peihui Ding, Doctor; Phone Number: 18957108518; Email: phding@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Need for molar extraction due to periodontal disease and plan for late implantation
3. No acute infection, such as abscess or effusion
4. 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
5. Presence of one adjacent tooth to the extraction site

Exclusion Criteria:

1. Smoking
2. Pregnancy or lactation
3. Untreated periodontal disease
4. Severe systemic conditions that contraindicate surgery (such as diabetes, heart disease, cancer etc.)
5. Under radiotherapy
6. Systemic disease or medication that influences bone metabolism and mucosal healing (such as immunosuppressants, phenytoin, bisphosphonates etc.)
7. Extraction of multiple adjacent teeth
8. Allergy to any of the materials used in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Collagen Membrane; ridge preservation with collagen membrane + collagenated bovine bone mineral	Procedure: alveolar ridge preservation; 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.
Experimental: Collagen Sponge; ridge preservation with collagen sponge + collagenated bovine bone mineral	Procedure: alveolar ridge preservation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline horizontal width of ridge at 6 months	horizontal width of ridge at 1, 3, 5mm below crest	baseline, at 6 months
change from baseline vertical height of ridge at 6 months	vertical height of ridge at the buccal and palatal/lingual plates	baseline, at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
width of keratinized tissue	measured from the MGJ to the mucosa margin at the mid-buccal aspect using a periodontal probe	at 6 months
thickness of mucosa	measured at the mid-buccal aspect using an endodontic file with a rubber stop	at 6 months
postoperative pain	using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)	at 2 weeks

Collaborators and Investigators

• Sponsor: The Dental Hospital of Zhejiang University School of Medicine
• Investigators: Principal Investigator: Peihui Ding, Doctor, The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: DHZhejiangU-2021（77）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No