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

Dental Implants Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04189328
• Other study ID #: 02_D012_82168
• Status: Completed
• Phase: N/A
• Start date: December 10, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: December 2019
• Source: Krishnadevaraya College of Dental Sciences & Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implants

Intervention

Procedure:
• dental implant placement using magnifying loupes and microsurgical instruments
microsurgical dental implant placement employin splt finger technique by Misch
• macrosurgical dental implant placement
macrosurgical placement of single dental implants

Locations

Country	Name	City	State
India	Krishnadevaraya college of dental sciences and hospital	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Krishnadevaraya College of Dental Sciences & Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peri-implant papilla height	mesial and distal peri implant papilla height is measured in millimeter	1 year
Primary	marginal gingiva	buccal marginal gingival height is measured	1 year
Primary	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
Primary	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
Primary	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	surgical time taken	the time taken right from the incision to the implant placement is watched and recorded.	1 day
Secondary	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
Secondary	probing depth	peri implant probing depth at each follow up was recorded	1 year
Secondary	plaque index	plaque scores were recorded at each follow up 0.-0.9 good 1.0-1.9-fair 2-3-poor	1 year
Secondary	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