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Clinical Trials/CTRI/2024/06/068805
CTRI/2024/06/068805Not yet recruitingNot Applicable

Comparative evaluation of crestal bone loss between SLA and RBM surface implants in Narrow Alveolar ridges with Osseo densification technique - An Observational clinical trial.

Harini K1 site in 1 country36 target enrollmentStarted: July 15, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
36
Locations
1
Primary Endpoint
Comparison of crestal bone loss between

Study Overview

Brief Summary

For optimal implant success, availability of adequate amounts of bone in terms of horizontal as well as vertical dimensions is the first requirement, but local conditions of edentulous alveolar ridges may be unfavorable for implant placement. The resorption patterns of alveolar bone after tooth loss or extraction due to trauma and, periodontal disease leads to unfavourable ride dimensions. The greatest amount of bone loss usually occurs in the horizontal dimension, mainly on the facial side of the ridge. There may also be loss of vertical ridge height, which has been reported to be the most pronounced on the buccal aspect. This resorption process results in a narrower and shorter ridge. Scipioni et al. suggests that wherever dental implants are placed, a minimum thickness of 1–1.5 mm of bone should remain on both buccal and lingual/palatal aspects of the implant(s) to ensure a successful outcome. This lead to look out for alterative procedures such as ridge expansion and ridge splitting using osteotomes, osseodensification using specialized surgical drills etc. Ridge expansion techniques have been suggested to expand the narrow alveolar ridge with implant placement in a single surgical visit. Expanding the alveolar ridge was suggested as an approach of implant site preparation using osseodensification (OD), a non-subtractive drilling technique. It makes use of burs (Densah) that are precisely made and rotate counter-clockwise to preserve bone volume and assist autograft compaction resulting in an outward strain from the osteotomy, which causes plastic deformation and expansion of the alveolar bone. Additionally, a narrow ridge could accommodate a greater implant diameter without inducing fenestration or bone dehiscence by adopting the OD method. Densah burs are all examples of modern ridge expansion instruments. Presently various implants are available with surface modifications like SLA and traditional RBM surface treatments. These implant surfaces have shown optimal long term success. However crestal bone loss after implant placement and restoration poses greater challenges to clinicians especially in narrow ridge situation. There is a lacunae in literature evidences on comparison of crestal bone level changes between SLA and RBM surface implants in narrow ridges expanded with osseodensification techniques. Hence current study is designed to evaluate the crestal bone level changes between SLA and RBM surface implants placed in Narrow Alveolar ridges by Osseodensification technique

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 55.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Narrow ridge 4-6mm (Moderate).
  • Tolstunov’s classification of alveolar ridge width.
  • Patients who are between 20-55 years of age.
  • All sites had to be healed sites, that is at least 6 months of post extraction healing was required.

Exclusion Criteria

  • 1.Pregnancy and lactating women 2.Smokers and HBA1c exceeding 6.3 3.Known allergry to any material or medication used in the study
  • Any previous history of head and neck radiation therapy 5.Chemotherapy in the last 12 months 6.Severe pyschologic problems 7.Patient not willing to sign the consent approved by the human tudies committee
  • Debilitating systemic diseases or conditions that have a clinically significant effect on without healing 9.History of oral or intravenous bisphosphonate use for more than 3 years.

Outcomes

Primary Outcomes

Comparison of crestal bone loss between

Time Frame: subjects will be followed at 0 4 8 12 16 weeks after implant | placement

SLA and RBM surface implants in narrow

Time Frame: subjects will be followed at 0 4 8 12 16 weeks after implant | placement

alveolar ridge

Time Frame: subjects will be followed at 0 4 8 12 16 weeks after implant | placement

Secondary Outcomes

  • 1.Comparison of primary stability between SLA and RBM surface implants in narrow alveolar ridges.(2.Comparison of secondary stability of SLA surface implants in narrow alveolar ridge using OD technique.)

Investigators

Sponsor
Harini K
Sponsor Class
Other [SELF FUNDED]
Responsible Party
Principal Investigator
Principal Investigator

Harini K

SRM Dental College

Study Sites (1)

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