Influence of Collagen Cone on Jumping Gap Management Around Dental Implants (implant)

April 18, 2025 updated by: Hala Fathy Abd El Fattah, Faculty of Dental Medicine for Girls
The present study will be performed to assess the clinical and radiographic effect of collagen cone for bone growth in immediate implants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Improve width and length of buccal plate of alveolar bone, bone density around dental implamts in esthetics zone.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12345
        • Hala Fathy Abd El-Fattah Azzam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged between 30-50 years.
  • Good general health.
  • Adequate bone volume at the implant site.
  • Non-compromised periodontal status.

Exclusion Criteria:

  • Presence of parafunctional habits (e.g., bruxism, clenching, excessive gum chewing, lip or fingernail biting).
  • Smokers.
  • Patients receiving chemotherapy or radiotherapy.
  • Alcohol or drug abuse.
  • Pregnancy and lactation.
  • Use of drugs that may affect bone metabolism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate Dental Implant Placement only
The control group will be assigned for the sites that undergo placement of immediate dental implant (N=8) only.
Procedure: Placement of Immediate Dental Implant Only
Participants will receive placement of an immediate dental implant without any additional material (N=8).
Active Comparator: Immediate Dental Implant Placement with Collagen Cone
The test group include those sites enrolled for placement of immediate dental implant (N=8) with application of collagen cone
Device: collagen cone (resorbable material used for socket sealing )
The test group include those sites enrolled for placement of immediate dental implant (N=8) with application of collagen cone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Bleeding Index
Time Frame: from 0 to 9 month

Assessment of peri-implant soft tissue bleeding using the modified bleeding index:

0 - No bleeding

  1. - Isolated bleeding spots
  2. - Confluent bleeding
  3. - Profuse bleeding unit of Measure: Score (0-3)
from 0 to 9 month
Vertical Bone Loss
Time Frame: from 0 to 9 month
Measurement of marginal vertical bone height loss around dental implants using CBCT imaging Unit of Measure: Millimeters (mm)
from 0 to 9 month
Buccal Plate Width
Time Frame: From 0 to 9 months
Measurement of buccal bone plate width at the implant site using CBCT. Unit of Measure: Millimeters (mm)
From 0 to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Dental Medicine for Girls

Investigators

  • Study Director: Abeer Gawish, professor, Azhar University
  • Study Director: lobna Abd-El Aziz, Lecturer, Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

April 12, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 18, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMPDR-103-2h

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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