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Clinical Trials/CTRI/2024/09/073313
CTRI/2024/09/073313RecruitingPhase 1/2

A comparative evaluation of immediate implant placement by Vestibular socket therapy between Dynamic navigation system and conventional placement in defective labial wall cases: A Randomized Clinical Trial.

Dr Ashish Jain Indian Society of Periodontology1 site in 1 country26 target enrollmentStarted: September 25, 2024Last updated:

Trial Snapshot

Phase
Phase 1/2
Status
Recruiting
Sponsor
Enrollment
26
Locations
1
Primary Endpoint
Buccal wall Thickness and marginal bone loss.

Study Overview

Brief Summary

Immediate implants placed conventionally have a high chance of encroaching the safe zone which results in both soft and hard tissue complications in the long run. By using this VST method, we can augment both hard and soft tissue at the extraction site. By using a Dynamic navigation system precise implant placement at 360° in esthetic areas, offering real-time adjustments during osteotomy for enhanced accuracy compared to static guides. The study is a randomized controlled clinical trial proposed to be done in the Department of Periodontics, Saveetha Dental College and Hospitals, Chennai. After patient recruitment, the patients are allotted using lot sampling and patient will be made to pick up the concealed envelop are divided into subsequent groups-

a)The control group is going to be the participants who will be receiving conventional immediate implants via VST. b)The test group will be receiving implants through DNS via VST.

Technique: Perform vestibular socket therapy by incising 1 cm apical to the tooth. Dissect vestibular pouch towards root apex for access. Use bur for osteotomy at the apex and release the ligament. Elevate root fragments and excavate apex. Place the implant with 360-degree contact using the DNS system. Use xenograft in bone defects with GBR membrane. Suture with 4-0 polypropylene and provide permanent prosthesis after period of temporization. The data from results are compared using Student’s T-test and One-way  ANOVA.  The primary objective is to assess buccal wall thickness and marginal bone loss between the two groups. The pink esthetic score and white esthetic score are also assessed secondarily.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • The tooth in the Maxillary anterior region which had undergone trauma, has root fracture or non-vital teeth with thin labial plate /dehiscence which is indicated for extraction and immediate implant placement.

Exclusion Criteria

  • Periapical lesions, smokers, pregnant and lactating women, and patients with systemic conditions.

Outcomes

Primary Outcomes

Buccal wall Thickness and marginal bone loss.

Time Frame: 6 months

Secondary Outcomes

  • Pink and white esthetic score(6 months post-operatively.)

Investigators

Sponsor
Dr Ashish Jain Indian Society of Periodontology
Sponsor Class
Other [Speciality society in Dentistry]
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Thaha A

Saveetha Institute of Medical and Technical sciences

Study Sites (1)

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