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Clinical Trials/CTRI/2024/10/076079
CTRI/2024/10/076079CompletedUnknown

A comparative in-vivo study between reverse conical neck and standard neck implants and its effect on crestal bone morphology and peri-implant soft tissue collar; a randomized clinical trail

Pinipe Christina1 site in 1 country22 target enrollmentStarted: November 15, 2024Last updated:

Trial Snapshot

Phase
Unknown
Status
Completed
Sponsor
Enrollment
22
Locations
1
Primary Endpoint
Radiographic crestal Bone levels around implant, Periimplant probing depth

Study Overview

Brief Summary

The success of dental implants is influenced by the amount of bone surrounding the implant. The design of the implant collar, particularly the reverse conical neck design, can affect bone remodelling. This design is thought to reduce bone loss, redistribute stress, and improve soft tissue health and also provide the bone ring formation on crest module.  **Matteo Danza, Chieti/Italy,****(2009)**conducted a study in which The concept of platform switching (PS)  can be successfully applied together with immediate loading as demonstrated in case series and histo-morphometrical evaluation in man. Starting from the platform switching  idea, this study elaborated the concept of Bone Platform Switching (BPS). The BPS is obtained by using dental fixture with a reverse conical neck. This type of implant gives an increased residual crestal bone volume around the implant neck and carries several advantages: a reduced mechanical stress in the crestal alveolar bone area, the repositioning of gingival papillae on the bone ring (that is the physiological condition), and a proper vascular supply to hard and bone tissue also in case of reduced inter-implant space. To verify if the concept of BPS really gives some advantages to reverse conical neck implants a retrospective analysis was performed on a case series of RCN implants. This study aims to compare the cresta bone loss and soft tissue health around standard neck implants and reverse conical neck implants to determine the effectiveness of the reverse conical design in preserving crestal bone and soft tissue.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Posterior edentulous spaces with adequate ridge dimension for implant placement.
  • Presence of a minimum of 2 mm of keratinized mucosa at the buccal aspects in the implant zone.
  • Minimum crestal bone width of 5 mm and bone architecture without undercuts and presence of 1 mm of bone bucco-lingual to the planned position in a favorable prosthetic situation from pre- operative CBCT.
  • Vertical bone height from bone crest to top of mandibular canal of 12 mm or more; a mesio-distal width of 6–10 mm .
  • Minimum vertical distance of 5 mm from the crestal mucosa of the potential implant site to the opposing dentition.
  • Absence of periapical pathology adjacent to the edentulous site.
  • Patients who are motivated, highly compliant, with good oral hygiene practice.

Exclusion Criteria

  • Anterior edentulous space.
  • Presence of active periodontal disease.
  • Patients with any systemic disease and medications that will interfere with treatment outcome.
  • Patients with known risk factors and risk modifiers which can influence the overall outcome of treatment were excluded from the study.
  • Pregnant and lactating women.
  • Persons who are not surgically fit for implant placement.

Outcomes

Primary Outcomes

Radiographic crestal Bone levels around implant, Periimplant probing depth

Time Frame: baseline, 3 months, 6 months

Secondary Outcomes

  • Correlation between Mucosal thickness and primary outcomes(baseline)

Investigators

Sponsor
Pinipe Christina
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Pinipe Christina

GSL dental college

Study Sites (1)

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