Soft Tissue Evaluation Around Implants Using Prf or a Palatal Pedicle

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.

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.

Study Overview

• Status: Unknown
• Conditions: Soft Tissue Augmentation
• Intervention / Treatment: Procedure: PRF; Procedure: Palatal Pedicle

Detailed Description

Immediate implant will be place and followed by soft tissue augmentation by PRF or palatal pedicle and the primary outcome is the pink esthetic score

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria

1. Absence of periodontal disease or a periapical infection
2. Adequate native bone to achieve implant primary stability
3. 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.

Exclusion criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PRF with immediate implants; Immediate implants placed and covered with two prf layers	Procedure: PRF; soft tissue augmentation by prf
ACTIVE_COMPARATOR: palatal pedicle graft; immediate implant placement followed by soft tissue augmentation by oalatal pedicle graft	Procedure: Palatal Pedicle; soft tissue augmentation by palatal pedicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pink Esthetic Score	photographs	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
facial gingival thickness	probe	5 months
mid-buccal gingival level	probe	5 months
interproximal gingival level	probe	5 months
- width of keratinized gingiva (KG	probe	5 months
Crestal bone loss	CBCT	5 months
Implant stability	ostel	5 months
Pain	VAS	5 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2017
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): October 1, 2018

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (ACTUAL): July 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 5, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Philoprotocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No