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

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05188196
• Other study ID #: DHZhejiangU-2021(77)
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: September 2023
• Source: The Dental Hospital of Zhejiang University School of Medicine
• Contact: Weida Li, master
• Phone: 0571-87219287
• Email: kyb[@]zjkq.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
China	The Affiliated Stomatology Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Dental Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline horizontal width of ridge at 6 months	horizontal width of ridge at 1, 3, 5mm below crest	baseline, at 6 months
Primary	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	width of keratinized tissue	measured from the MGJ to the mucosa margin at the mid-buccal aspect using a periodontal probe	at 6 months
Secondary	thickness of mucosa	measured at the mid-buccal aspect using an endodontic file with a rubber stop	at 6 months
Secondary	postoperative pain	using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)	at 2 weeks