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NCT Number: NCT06552065

Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants

Comparative evaluation of cross-linked collagen membrane with and without silk fibroin around Immediate Dental Implants -Randomized controlled trial.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

About this study

Periodontal disease is an inflammatory and infectious disease affecting the tooth supporting structures leading to tooth loss when left untreated.The detrimental effect of periodontitis results in soft tissue and hard tissue loss. Bone defects has often resulted from tumor resection, congenital malformation, trauma, fractures, surgery, periodontitis or around implants in dentistry, as well as from diseases, such as osteoporosis or arthritis.These deficiencies have been overcome through various treatment modalities.It is a well-established fact that the cells from the periodontal ligament have the potential for regeneration of the tooth attachment apparatus. In addition, bone grafts and membranes have been used to regenerate the lost bone.

Among the membranes, autogenous connective tissue graft remains as gold standard. Collagen is biocompatible natural polymer that has a good function to promote new tissue formation. In the proposed study, immediate implants with compromised bone support, cross-linked bovine collagen membrane will be used. It is a naturally occurring protein, having excellent biocompatibility, and hemostatic and chemotactic characteristics for gingival fibroblasts and periodontal ligaments. Further, it is resistant to tension, controllable biodegradability, is non cytotoxic, low antigenicity, and excellent anti-inflammatory characteristics. It is naturally reabsorbed by microorganisms, easy to manipulate and has a molecular structure with little variance concerning the animal from which the collagen is extracted, leading to improved immunogenicity.

Bovine collagen is selected to enhance the biological function of silk fibroin, as composite membrane for enhancement of gingival thickness. Thus, considering all these characteristics, silk fibroin is incorporated into collagen membrane for evaluation .As there is no literature assessing this composite membrane, the aim of this study Compare evaluation of Cross-linked collagen membrane with and without Silk fibroin around Immediate Dental Implants Randomized controlled trial will be undertaken.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Systemically healthy patients in the age group of 18 to 55years.
  • Patients undergoing immediate implant placement with gingival thickness ≤ 1mm
  • Stage II /Stage III and Grade B Periodontitis patients.
  • Radiographic assessment using Radiovisiography (RVG) with grid.

Exclusion criteria

  • Patients having allergies with collagen and silk products.
  • Medical conditions contraindicating surgical interventions.
  • Known smokers and alcoholic.
  • Acute infections at the site of extraction. Ex Abscess.
  • Patients who have undergone radiotherapy or chemotherapy.

Treatment and study plan

collagen with silk fibroin membrane

Other

A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol.

An immediate implant with collagen membrane ( comparative group) will be placed according to the standard protocol .

The surgical wound closure will be coapted with mattress and single interrupted sutures

cross linked collagen membrane

Other

A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with collagen with silk fibroin membrane (experimental group) will be placed according to the standard protocol.

Primary outcomes

  1. To assess wound healing, gingival thickness and keratinized tissue width

    Time frame: pre implant placement , 6 weeks , 12 weeks

    Gingival tissue thickness assessment will be done at the site of implant placement 1.5 mm below the gingival margin of adjacent tooth. Local anaesthesia will be administered before the procedure and an Endodontic K-file with silicone disc stop will be used to measure. The depth will be measured with UNC-15 probe.

    Apico-coronal width of keratinized tissue is measured as the distance from the mucogingival junction to the gingival margin, with the mucogingival junction determined using Schiller's Potassium Iodide Solution.

Secondary outcomes

  1. Radiovisiography with grid

    Time frame: pre implant placement , 6 weeks , 12 weeks

    assess increase in bone volume

Study contacts

Contact information is provided by the study sponsor or research team.

MLV Prabhuji, mds

CONTACT

[email protected]

9448057407

jyoti naik, bds

CONTACT

[email protected]

7337673040

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study title

Comparative Evaluation of Cross-linked Collagen Membrane With and Without Silk Fibroin Around Immediate Dental Implants -Randomized Controlled Trial.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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