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Application of new adhesive material for better bone healing around immediately placed dental implants

Development and Implication of Adhesive Scaffold for Regenerative and Mechanical Advances in Immediate Dental Implants

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072462
Enrollment
20
Registered
2024-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: Tissue engineered photopolymerizable injectable adhesive bone regenerative hydrogel scaffold: A tissue engineered adhesive photopolymerizable injectable hydrogel scaffold made of Gelati

Sponsors

King George Medical University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy adult patients 18 to 60 years both male and female having one or more teeth indicated for extraction are included they must be Negative for allergic testing for ABRS and ready to give written informed consent The jumping gap should be at least 2mm with all 4 cortical plate walls intact around the socket and have D1 D2 or D3 bone type

Exclusion criteria

Exclusion criteria: subjects with history of Smoking alcohol tobacco chewing drugs systemic conditions requiring medication pregnancy lactation history of allergic predisposition are excluded there should not be any acute periapical abcess or cysts existing ridge defect missing one or more cortical bone at the concerned site also mandibular anterior region and D4 bone are excluded

Design outcomes

Primary

MeasureTime frame
To determine the effect of ABRS on the primary stability on the dental implants placed in fresh extraction sockets To assess the effect of ABRS on crestal bone healing and regeneration To determine the quality and quantity of bone formed around the dental implants To conduct a comparative evaluation of all the above parameters with the market control Timepoint: Primary stability will be measured by Radio Frequency Analyzer RFA and insertion torque at baseline 0 The crestal bone level will be measured radiographically at 0 3 6 and 12 months and clinically by probing pocket depth assessment at 0 3 6 and 12 months For bone healing Peri ?implant crevicular fluid samples will be obtained at 3 7 & 14 days after implant placement for Multiplexing Quality of bone formed is assessed by DEXA scan at 0 3 6 and 12 months

Secondary

MeasureTime frame
to assess the effect of ABRS on secondary stability on functional loads. to assess the effect of ABRS on the maintenance and healing of soft tissue profiles around dental implant crowns. To assess the functional ability of the implant prosthesis.Timepoint: secondary stability will be measured by a radio frequency analyzer RFA at 3,6 and 12 months. soft tissue profile assessment is done by pink esthetic score at 0,7,14 and 28 days and early wound healing index at 0,3,7 and 14 days. for functional assessment, the PROM questionnaire will be filled at 1,3 and 6 months

Countries

India

Contacts

Public ContactRameshwari Singhal

King Georges Medical University

drsamikshadubey@gmail.com9588352789

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026