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

ConditionPeriodontitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe Dental Hospital of Zhejiang University School of Medicine

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Smoking

Pregnancy or lactation

Untreated periodontal disease

Severe systemic conditions that contraindicate surgery (such as diabetes, heart disease, cancer etc.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • alveolar ridge preservation

    Procedure/Surgery

    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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Collagen MembraneActive comparator 1 intervention
Group B: Collagen SpongeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

change from baseline horizontal width of ridge at 6 months

horizontal width of ridge at 1, 3, 5mm below crest

Time frame
baseline, at 6 months
2

change from baseline vertical height of ridge at 6 months

vertical height of ridge at the buccal and palatal/lingual plates

Time frame
baseline, at 6 months

Secondary outcomes

1

width of keratinized tissue

measured from the MGJ to the mucosa margin at the mid-buccal aspect using a periodontal probe

Time frame
at 6 months
2

thickness of mucosa

measured at the mid-buccal aspect using an endodontic file with a rubber stop

Time frame
at 6 months
3

postoperative pain

using a visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst pain imaginable)

Time frame
at 2 weeks

Other outcomes

Sponsors and contacts

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