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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorKrishnadevaraya College of Dental Sciences & Hospital

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • collagen with silk fibroin membrane

    Other intervention

    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 intervention

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: 10 will receive cross -linked collagen with silk fibroin membrane around immediate implant.Experimental treatment 2 interventions
Group B: 10 will receive cross linked collagen membrane around immediate implantActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

To assess wound healing, gingival thickness and keratinized tissue width

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.

Time frame
pre implant placement , 6 weeks , 12 weeks

Secondary outcomes

1

Radiovisiography with grid

assess increase in bone volume

Time frame
pre implant placement , 6 weeks , 12 weeks

Other outcomes

Sponsors and contacts

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