Modified Pedicle Subepithelial Connective Tissue Graft for Interdental Papillary Reconstruction Around Delayed Implants in the Esthetic Zone: A Case Series Trail (delay implant)

تعديل النسيج الضام عنيق تحت الظهارة من أجل إعادة بناء حليمي بين الأسنان حول الزراعه المتأخره في المنطقة الجمالية

This case series trial aims to evaluate the effect of a modified pedicle subepithelial connective tissue graft in creating anatomical papilla around one-stage delayed implant in the esthetic zone to establish better esthetics.

Study Overview

• Status: Unknown
• Conditions: Papilla Reconstruction
• Intervention / Treatment: Procedure: papilla reconstruction

Detailed Description

• Preparation of the implant site will be prepared by a crestal incision on the ridge bisecting the existing keratinized mucosa and vertical releasing incisions extending to the vestibule. The papillae of the adjacent teeth are not included in the flap design.
• A full thickness flap will be raised buccally exposing the underlined ridge of the implant site. A surgical drill guide will be used for the precise placement of the pilot drill. After pilot drill application, the osteotomy will be prepared with the corresponding size of parallel drill.
• The implant will be placed in the recipient site by means of an insertion device. The implant neck will be positioned flushing with the crestal bone level.
• The healing abutment extension of the implant will be placed in such a way that the head of the implant protruded about 2 to 3 mm from the bone crest.
• Reassessment of the case to assure absence of any signs of inflammation and presence of normal tissues before the surgical procedure

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Sadek mohamed, master; Phone Number: 3 23634965; Email: ahmed.sadek@dentistry.edu.cu.eg
• Study Contact Backup: Name: weam Ahmed el batawy, PHD; Phone Number: 3 23634965; Email: weamelbatawy@dentistry.edu.cu.eg

Study Locations

• Egypt
  • Manial
    • Cairo, Manial, Egypt, 11865
      • Recruiting
      • Cairo University faculty of dentistry
      • Contact: Ahmed Sadek mohamed, master; Phone Number: 3 23634965; Email: ahmed.sadek@dentistry.edu.cu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Exclusion Criteria:

1. Pregnant females.
2. Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, et al., 2009)
3. Handicapped and mentally retarded patients.
4. Patients undergoing radiotherapy.
5. Presence of systemic disease that would affect wound healing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: delayed implant; Patients 18 years or older.; Periodontally and systemically healthy.; Sufficient bone width and height for implant placement; Adequate mesiodistal width and inter-arch space for placement of a delayed implant.; Full mouth plaque index less than 15% (Bentley and Disney, 1995); cooperative patients who will comply to follow up visits	Procedure: papilla reconstruction; subepithelial connective tissue graft for interdental papillary reconstruction around delayed; Other Names: create papilla around delayed implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
papilla height	Periodontal probe and reference line	3 month

Collaborators and Investigators

• Sponsor: Ahmed Sadek Mohamed

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2020
• Primary Completion (Actual): May 20, 2020
• Study Completion (Anticipated): September 14, 2021

Study Registration Dates

• First Submitted: April 4, 2021
• First Submitted That Met QC Criteria: April 11, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 11, 2021
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PER 111; per 122 (Registry Identifier: implant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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