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

NCT05188196 | Recruiting

• 1 other identifier: DHZhejiangU-2021（77）
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• width of keratinized tissue

  at 6 months

• thickness of mucosa

  at 6 months

• postoperative pain

  at 2 weeks

Study Arms (2)

Collagen Membrane

ACTIVE COMPARATOR

ridge preservation with collagen membrane + collagenated bovine bone mineral

Procedure: alveolar ridge preservation

Collagen Sponge

EXPERIMENTAL

ridge preservation with collagen sponge + collagenated bovine bone mineral

Procedure: alveolar ridge preservation

Interventions

alveolar ridge preservation PROCEDURE

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.

Collagen Membrane; Collagen Sponge

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Dental Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Peihui Ding, Doctor

  The Affiliated Stomatology Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weida Li, master

CONTACT

0571-87219287; kyb@zjkq.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: April 30, 2022
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)