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

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

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

Study Overview

• Status: Completed
• Conditions: Dental Implants
• Intervention / Treatment: Procedure: macrosurgical dental implant placement; Procedure: dental implant placement using magnifying loupes and microsurgical instruments

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 562157
      • Krishnadevaraya college of dental sciences and hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: control group; conventional macrosurgical implant placement	Procedure: macrosurgical dental implant placement; macrosurgical placement of single dental implants
EXPERIMENTAL: test group; microsurgical implant placement	Procedure: dental implant placement using magnifying loupes and microsurgical instruments; microsurgical dental implant placement employin splt finger technique by Misch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peri-implant papilla height	mesial and distal peri implant papilla height is measured in millimeter	1 year
marginal gingiva	buccal marginal gingival height is measured	1 year
jemt papilla index	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	1 year
crestal bone loss	radiographic crestal bone level around the implants measured from 1st thread of the implant to the coronal or apical most bone level in millimeters.	1 year
pink esthetic score	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical time taken	the time taken right from the incision to the implant placement is watched and recorded.	1 day
visual analogue scale score	aesthetic score by the outcome investigator using VAS score sheet of 10 points. 1 being most painful and 10 being painless	1 year
probing depth	peri implant probing depth at each follow up was recorded	1 year
plaque index	plaque scores were recorded at each follow up 0.-0.9 good 1.0-1.9-fair 2-3-poor	1 year
gingival index	gingival index scores were recorded at each followup 0.1-1-mild gingivitis 1.1-2- moderate gingivitis 2.1-3 severe gingivitis	1 year

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital
• Investigators: Principal Investigator: Dr.Joann pauline George, MDS, Krishnadevaraya college of dental sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2017
• Primary Completion (ACTUAL): September 30, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (ACTUAL): December 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 6, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 02_D012_82168

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No