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Completed

NCT Number: NCT04189328

Peri-implant Papillary Height Comparison in Microsurgically and Macrosurgically Placed Dental Implants

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

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Key information

Conditions

Dental Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krishnadevaraya college of dental sciences and hospital

Bangalore, Karnataka, 562157, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dental implant placement using magnifying loupes and microsurgical instruments

Procedure

microsurgical dental implant placement employin splt finger technique by Misch

macrosurgical dental implant placement

Procedure

macrosurgical placement of single dental implants

Primary outcomes

  1. peri-implant papilla height

    Time frame: 1 year

    mesial and distal peri implant papilla height is measured in millimeter

  2. marginal gingiva

    Time frame: 1 year

    buccal marginal gingival height is measured

  3. 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;

    • = 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;
    • = 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;
    • = the papilla fills the entire proximal space and is harmonious with the adjacent papillae, and soft-tissue contour is optimal;
    • = the papillae are hyperplastic and cover too much of the implant or the adjacent tooth, and the soft-tissue contour is irregular

  4. 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.

  5. 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

Secondary outcomes

  1. surgical time taken

    Time frame: 1 day

    the time taken right from the incision to the implant placement is watched and recorded.

  2. visual analogue scale score

    Time frame: 1 year

    aesthetic score by the outcome investigator using VAS score sheet of 10 points. 1 being most painful and 10 being painless

  3. probing depth

    Time frame: 1 year

    peri implant probing depth at each follow up was recorded

  4. plaque index

    Time frame: 1 year

    plaque scores were recorded at each follow up 0.-0.9 good 1.0-1.9-fair 2-3-poor

  5. gingival index

    Time frame: 1 year

    gingival index scores were recorded at each followup 0.1-1-mild gingivitis 1.1-2- moderate gingivitis 2.1-3 severe gingivitis

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2019
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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