NCT03224442

Brief Summary

Clinical Evaluation of Peri-Implant Soft Tissue Around Immediately Placed Implants Using PRF Membrane Versus The Palatal Pedicle Soft Tissue Graft: A Randomized Controlled Clinical Trial.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

July 12, 2017

Last Update Submit

November 5, 2017

Conditions

Soft Tissue Augmentation

Outcome Measures

Primary Outcomes (1)

  • Pink Esthetic Score

    photographs

    5 months

Secondary Outcomes (7)

  • facial gingival thickness

    5 months

  • mid-buccal gingival level

    5 months

  • interproximal gingival level

    5 months

  • - width of keratinized gingiva (KG

    5 months

  • Crestal bone loss

    5 months

  • +2 more secondary outcomes

Study Arms (2)

PRF with immediate implants

EXPERIMENTAL

Immediate implants placed and covered with two prf layers

Procedure: PRF

palatal pedicle graft

ACTIVE COMPARATOR

immediate implant placement followed by soft tissue augmentation by oalatal pedicle graft

Procedure: Palatal Pedicle

Interventions

PRFPROCEDURE

soft tissue augmentation by prf

PRF with immediate implants
Palatal PediclePROCEDURE

soft tissue augmentation by palatal pedicle

palatal pedicle graft

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Absence of periodontal disease or a periapical infection
  • Adequate native bone to achieve implant primary stability
  • The need for a single-tooth replacement in the anterior maxilla (from the second bicuspid to the second bicuspid), subsequent to an inevitable tooth extraction.

You may not qualify if:

  • Systemic conditions/disease that contraindicated surgery
  • Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
  • Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
  • Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
  • Patients who have inadequate interarch space for the prosthetic part.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 21, 2017

Study Start

December 1, 2017

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

November 7, 2017

Record last verified: 2017-11