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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04189328
Enrollment
20
Registered
2019-12-06
Start date
2017-12-10
Completion date
2019-09-30
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implants

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.

Interventions

PROCEDUREdental implant placement using magnifying loupes and microsurgical instruments

microsurgical dental implant placement employin splt finger technique by Misch

PROCEDUREmacrosurgical dental implant placement

macrosurgical placement of single dental implants

Sponsors

Krishnadevaraya College of Dental Sciences & Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
pink esthetic score1 yearscoring 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
peri-implant papilla height1 yearmesial and distal peri implant papilla height is measured in millimeter
marginal gingiva1 yearbuccal marginal gingival height is measured
jemt papilla index1 yearpapillary 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
crestal bone loss1 yearradiographic crestal bone level around the implants measured from 1st thread of the implant to the coronal or apical most bone level in millimeters.

Secondary

MeasureTime frameDescription
surgical time taken1 daythe time taken right from the incision to the implant placement is watched and recorded.
visual analogue scale score1 yearaesthetic score by the outcome investigator using VAS score sheet of 10 points. 1 being most painful and 10 being painless
probing depth1 yearperi implant probing depth at each follow up was recorded
plaque index1 yearplaque scores were recorded at each follow up 0.-0.9 good 1.0-1.9-fair 2-3-poor
gingival index1 yeargingival index scores were recorded at each followup 0.1-1-mild gingivitis 1.1-2- moderate gingivitis 2.1-3 severe gingivitis

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026