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

NCT04189328 | Completed DMC

• 1 other identifier: 02_D012_82168
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (5)

• 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; 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

  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 Outcomes (5)

• surgical time taken

  1 day

• visual analogue scale score

  1 year

• probing depth

  1 year

• plaque index

  1 year

• gingival index

  1 year

Study Arms (2)

control group

ACTIVE COMPARATOR

conventional macrosurgical implant placement

Procedure: macrosurgical dental implant placement

test group

EXPERIMENTAL

microsurgical implant placement

Procedure: dental implant placement using magnifying loupes and microsurgical instruments

Interventions

dental implant placement using magnifying loupes and microsurgical instruments PROCEDURE

microsurgical dental implant placement employin splt finger technique by Misch

test group

macrosurgical dental implant placement PROCEDURE

macrosurgical placement of single dental implants

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Krishnadevaraya college of dental sciences and hospital

Bangalore, Karnataka, 562157, India

Location

Study Officials

• Dr.Joann pauline George, MDS

  Krishnadevaraya college of dental sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: December 10, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Locations

IN (1)