NCT06588998

Brief Summary

Peri-implant soft tissue dehiscences represent a common complication in implant dentistry, often leading to esthetic and functional challenges. Current treatment options, including Xengenic cortical membranes and connective tissue graft with coronally advanced flap, aim to promote soft tissue regeneration and improve clinical outcomes. However, there is a need for comparative studies to determine the optimal treatment modality for peri-implant soft tissue dehiscences.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

September 5, 2024

Last Update Submit

September 5, 2024

Conditions

Immediate ImplantConnective Tissue Graft

Outcome Measures

Primary Outcomes (1)

  • peri implant soft tissue thickness

    six months

Secondary Outcomes (1)

  • pink esthetic score

    six months

Study Arms (2)

Xengenic Cortical membranes

EXPERIMENTAL
Device: Xengenic Cortical membranes

connective tissue graft

ACTIVE COMPARATOR
Procedure: connective tissue graft

Interventions

Xengenic Cortical membranesDEVICE

soft tissue surgery around dental implant dehiscence

Also known as: Osteobiol ,flexible xenograft cortical sheet from Technoss,USA
Xengenic Cortical membranes
connective tissue graftPROCEDURE

soft tissue surgery around dental implant dehiscence

connective tissue graft

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults (20-50) years old. •peri-implant soft tissue dehiscence . •Thin gingival phenotype. •Optimal compliance as evidenced by no missing treatment appointments and positive attitude towards oral hygiene.

You may not qualify if:

  • Medically compromised patients and systemic conditions precluding implant and periodontal surgery. •Smokers, diabetics, pregnant or lactating women. •History of chemotherapy, radiotherapy in head and/or neck region. •Bisphosphonate therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TantaU

Tanta, Gharbia Governorate, Egypt

RECRUITING

Central Study Contacts

amr anwar ellithy, MSC

CONTACT

00201066767062amr.yousef@dent.tanta.edu.eg

bassem nabil elfahl, PHD

CONTACT

+20 114 009 0390

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

September 5, 2024

First Posted

September 19, 2024

Study Start

June 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

EG(1)