Soft Tissue Evaluation Around Implants Using Prf or a Palatal Pedicle

Soft Tissue Augmentation Clinical Trial

Official title:

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 Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03224442
• Other study ID #: Philoprotocol
• Status: Not yet recruiting
• Phase: N/A
• First received: July 12, 2017
• Last updated: November 5, 2017
• Start date: December 1, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: November 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: October 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Soft Tissue Augmentation

Intervention

Procedure:
• PRF
soft tissue augmentation by prf
• Palatal Pedicle
soft tissue augmentation by palatal pedicle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pink Esthetic Score	photographs	5 months
Secondary	facial gingival thickness	probe	5 months
Secondary	mid-buccal gingival level	probe	5 months
Secondary	interproximal gingival level	probe	5 months
Secondary	- width of keratinized gingiva (KG	probe	5 months
Secondary	Crestal bone loss	CBCT	5 months
Secondary	Implant stability	ostel	5 months
Secondary	Pain	VAS	5 months