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Keratinized Tissue Augmentation Using Porcine Collagen Matrix (Mucoderm®) Around Dental Implant

NCT ID: NCT06753084

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-07-25

Brief Summary

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Aim of the Study To evaluate the using of porcine collagen matrix for keratinized tissue augmentation around delayed dental implant.

Primary Outcome:

Peri-implant keratinized mucosal width and thickness following the use of porcine collagen matrix using (Mucoderm®-Botiss gmbh) compared to the gold standard FGG augmentation.

Secondary Outcome:

1. Crestal bone change (CBC)
2. Pocket depth (PD)
3. Bleeding on probing (BOP)
4. Plaque index (PI) PICOT

P: Population:

Patient with suitable ridge dimension for delayed implant placement.

I: Intervention:

Implant insertion followed by porcine collagen matrix soft tissue augmentation

C: Control:

Autogenous FGG

O: Outcomes

* Enhancing keratinized mucosal width and thickness
* Evaluating :

1. Crestal bone change (CBC)
2. perimplant Pocket depth (PD)
3. Bleeding on probing (BOP)
4. Plaque index (PI)
5. Modified PES. T: Time A 6 months follow up .

Detailed Description

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this study aiming to augment KMW with FGG and MUCODERM following apically positioned flap the primary outcomes to measure is KMW and MT

Conditions

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Keratinized Mucosa

Keywords

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keratinized tissue width , porcine collagen matrix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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KTW augmentation using FGG

KTW augmentation using apically positioned flap combined with FGG from palatal mucosa

Group Type ACTIVE_COMPARATOR

Alloderm

Intervention Type PROCEDURE

the study is done to patient who lacks of keratinized mucosa width by apically positioned flap and using of FGG as gold standard and Mucoderm as compartive group

KTW augmentation using porcine collagen matrix

KTW augmentation using apically positioned flap combined with porcine collagen matrix

Group Type EXPERIMENTAL

Alloderm

Intervention Type PROCEDURE

the study is done to patient who lacks of keratinized mucosa width by apically positioned flap and using of FGG as gold standard and Mucoderm as compartive group

Interventions

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Alloderm

the study is done to patient who lacks of keratinized mucosa width by apically positioned flap and using of FGG as gold standard and Mucoderm as compartive group

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1- Partially or fully edentulous sites with previous implant placed in posterior maxillary or mandibular areas.

2- Inadequate keratinized tissue ≤2 3- Patient age ranged from 20 to 45 years old for both genders. 4- Submerged Osteointegrated implants with no sings of inflammation before implant insertion.

5- Optimal compliance as evidenced by no missed treatment appointments and positive attitude toward oral hygiene.

Exclusion Criteria

* 1- Smokers 2- Pregnant or lactating female 3- Treatment with any systemic drug that could affect wound healing (ex- corticosteroids ) 4- History of systemic disease affect wound healing ex diabetes 5- Patient with bruxism and parafunctional habits. 6- Limited inter arch restoration space.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Misr University for Science and Technology

OTHER

Sponsor Role collaborator

ahmed amer

OTHER

Sponsor Role lead

Responsible Party

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ahmed amer

teaching assistant periodontics department faculty of dentistry

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Misr university for science and technology

Giza, NJ, Egypt

Site Status

Misr university for science and technology

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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KTW Managment

Identifier Type: -

Identifier Source: org_study_id