Influence of Collagen Cone on Jumping Gap Management Around Dental Implants

NCT06945562 | Completed

• 1 other identifier: OMPDR-103-2h
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will be performed to assess the clinical and radiographic effect of collagen cone for bone growth in immediate implants.

Conditions

Tooth Loss

Keywords

immediate implant; collagen cone; esthatic zone; jumping gap

Outcome Measures

Primary Outcomes (3)

• Clinical Bleeding Index

  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

  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

  Measurement of buccal bone plate width at the implant site using CBCT. Unit of Measure: Millimeters (mm)

  From 0 to 9 months

Study Arms (2)

Immediate Dental Implant Placement only

ACTIVE COMPARATOR

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

Immediate Dental Implant Placement with Collagen Cone

ACTIVE COMPARATOR

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 )

Interventions

collagen cone (resorbable material used for socket sealing ) DEVICE

The test group include those sites enrolled for placement of immediate dental implant (N=8) with application of collagen cone

Immediate Dental Implant Placement with Collagen Cone

Placement of Immediate Dental Implant Only PROCEDURE

Participants will receive placement of an immediate dental implant without any additional material (N=8).

Immediate Dental Implant Placement only

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (1)

Hala Fathy Abd El-Fattah Azzam

Cairo, 12345, Egypt

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Abeer Gawish, professor

  Al-Azhar University

  STUDY DIRECTOR

• lobna Abd-El Aziz, Lecturer

  Al-Azhar University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master's degree student at oral medicine, peridontology ,oral diagnosis and oral Radiology Department, faculty of Dental Medicine for Girls ,Al Azhar university

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: April 25, 2025
• Study Start: April 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)