Clinical trial NCT04189328: Peri-implant Papillary Height Comparison in Microsurgically and Macrosurgically Placed Dental Implants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: peri-implant papilla height
timeFrame: 1 year
measure: marginal gingiva
timeFrame: 1 year
measure: jemt papilla index
timeFrame: 1 year
measure: crestal bone loss
timeFrame: 1 year
measure: pink esthetic score
timeFrame: 1 year
Secondary outcomes:
measure: surgical time taken
timeFrame: 1 day
measure: visual analogue scale score
timeFrame: 1 year
measure: probing depth
timeFrame: 1 year
measure: plaque index
timeFrame: 1 year
measure: gingival index
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya college of dental sciences and hospital
state: Karnataka
Study officials:
affiliation: Krishnadevaraya college of dental sciences
name: Dr.Joann pauline George, MDS
role: PRINCIPAL_INVESTIGATOR
References: