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Clinical Trials/CTRI/2023/10/058222
CTRI/2023/10/058222Not yet recruitingPhase 2

Assessment of wound healing using different tissue regeneration materials in mandibular tooth extraction - A Prospective Study

Dr. Rajesh P1 site in 1 country90 target enrollmentStarted: May 10, 2023Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
Pain, inflammation and infection using Landry’s wound healing scale.

Study Overview

Brief Summary

The aim of the study is to Compare analyse wound healing in extraction socket using platelet-rich plasma fibrin with or without platelet rich fibrin based nanocomposite. Patients who visited the department of oral and maxillofacial surgery, chettinad dental college and research institute, will be screened and patients indicated for tooth extraction according to the inclusion and exclusion criteria will be selected for the study and randomly grouped into 9 different groups with 10 each such as Group 1: control group Group 2 : Platelet rich fibrin (PRF) Group 3: PRF + Silver nanoparticles Group 4: PRF + Titanium nanoparticles Group 5: PRF + Chitosan nanoparticles Group 6: PRF + Silver nanoparticles + Titanium nanoparticles Group 7: PRF + Silver nanoparticles + Chitosan nanoparticles Group 8 : PRF + Titanium nanoparticles + Chitosan nanoparticles Group 9 : PRF + Silver nanoparticles + Chitosan nanoparticles + Titanium nanoparticles Extraction of mandibular teeth will be done for all the subjects under local anaesthesia followed by a tissue regeneration material. A follow up of the patient will be done on the 3rd day, 7th day, 6 weeks. The extraction site will be assessed for pain, inflammation and infection. Landry’s wound healing scale will be used to assess the healing process. IPR scale will aso be used to assess the healing at the inflammatory, proliferative and remodelling phases of wound healing. This will be done at the 3rd day corresponding to inflammatory phase, 7th day corresponding to the proliferative phase and after 6 weeks corresponding to the remodeling phase. In the study, appreciable amount of bone regeneration is expected to be observed in the experimental groups when compared to the control sites where no PRF was used. All the procedures performed in the study involves no risk or harm to the study population and complies with the ethical standards

Study Design

Study Type
Interventional
Allocation
Permuted block randomization, fixed
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
25.00 Year(s) to 45.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Extraction of permanent mandibuar molar teeth performed for several reasons including dental caries, periodontal disease, failed dental treatment, prosthetic indications and other reasons.

Exclusion Criteria

  • •Teeth which can be save endodontically patient with systemic complication Patient with bleeding disorders Patients with Bone disorders.

Outcomes

Primary Outcomes

Pain, inflammation and infection using Landry’s wound healing scale.

Time Frame: 3rd day, 7th day, 6th week and 12th week

Secondary Outcomes

  • IPR scale will aso be used to assess the healing at the inflammatory,(proliferative and remodelling phases of wound healing)

Investigators

Sponsor
Dr. Rajesh P
Sponsor Class
Other [self]

Study Sites (1)

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