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Clinical Trials/NCT04189328
NCT04189328
Completed
N/A

Clinical and Radiological Comparison of Peri Implant Soft Tissue Parameters and Crestal Bone Loss Around Microsurgically and Macrosurgically Placed Implants: A Randomised Controlled Clinical Trail

Krishnadevaraya College of Dental Sciences & Hospital1 site in 1 country20 target enrollmentDecember 10, 2017
ConditionsDental Implants

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dental Implants
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Enrollment
20
Locations
1
Primary Endpoint
peri-implant papilla height
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This study compares the peri-implant soft tissue and crestal bone loss around single implants when placed macrosurgically and microsurgically.

Detailed Description

Black triangles in dentition especially in the anterior teeth would pose an esthetic concern. Interdental papilla height is crucial for eliminating this black triangle. 32 participants, 16 in two groups were assigned randomly. Microsurgical approach using microsurgical instruments and magnifying loupes were used for one group participants and similar procedure without magnifying loupes and microsurgical instruments was done in the other group. comparsion of the microsurgical outcome is done by measuring peri implant papilla gain and radiographic crestal bone loss will be done between the groups.

Registry
clinicaltrials.gov
Start Date
December 10, 2017
End Date
September 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients desiring implant placement for replacement of missing tooth and willing to participate in the study
  • Non smokers
  • Patients who do not report any relevant medically comprimising conditions or had not received any radiation therapy in head and neck region for cancer therapy.
  • Subjects with satisfactory residual ridges who demonstrated adequate bucco-lingual and mesio-distal space for implant placement, that facilitates primary stability.
  • Patients who demonstrate Plaque Index \<10% and good compliance.
  • Full mouth bleeding scores ≤25% before the implant placement.
  • Sites with sufficient band of keratinised mucosa.

Exclusion Criteria

  • • Pregnant and lactating females
  • Patients on anticancer therapy and immunosuppressant drugs.
  • Implants to be placed in sites with previous periodontal disease
  • Bleeding disorder or on anticoagulant therapy
  • Systemic diseases that would negatively influence wound healing

Outcomes

Primary Outcomes

peri-implant papilla height

Time Frame: 1 year

mesial and distal peri implant papilla height is measured in millimeter

jemt papilla index

Time Frame: 1 year

papillary height gained around implant is scored using jemt papilla index 0 = no papilla and no indication of a curvature of the soft tissue adjacent to the implant crown are present; 1. = less than one-half of the papilla height is present, and a convex curvature of the soft tissue adjacent to the implant crown and adjacent tooth can be observed; 2. = at least one-half of the papilla height is present but not to the contact point between the teeth, the papilla is not completely harmonious with the adjacent papillae between the permanent teeth, and soft tissue is harmonious with adjacent teeth; 3. = the papilla fills the entire proximal space and is harmonious with the adjacent papillae, and soft-tissue contour is optimal; 4. = the papillae are hyperplastic and cover too much of the implant or the adjacent tooth, and the soft-tissue contour is irregular

marginal gingiva

Time Frame: 1 year

buccal marginal gingival height is measured

pink esthetic score

Time Frame: 1 year

scoring assigned to 7 soft tissue criteria by an examiner as 0,1,2,3 and the average of the total score is considered the final score. a maximum score of 14 can be alloted

crestal bone loss

Time Frame: 1 year

radiographic crestal bone level around the implants measured from 1st thread of the implant to the coronal or apical most bone level in millimeters.

Secondary Outcomes

  • plaque index(1 year)
  • gingival index(1 year)
  • surgical time taken(1 day)
  • visual analogue scale score(1 year)
  • probing depth(1 year)

Study Sites (1)

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