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

A

ahmed amer

Status and phase

Completed
Phase 1

Conditions

Keratinized Mucosa

Treatments

Procedure: Alloderm

Study type

Interventional

Funder types

Other

Identifiers

NCT06753084
KTW Managment

Details and patient eligibility

About

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 .

Full description

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

Enrollment

22 patients

Sex

All

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

22 participants in 2 patient groups

KTW augmentation using FGG
Active Comparator group
Description:
KTW augmentation using apically positioned flap combined with FGG from palatal mucosa
Treatment:
Procedure: Alloderm
KTW augmentation using porcine collagen matrix
Experimental group
Description:
KTW augmentation using apically positioned flap combined with porcine collagen matrix
Treatment:
Procedure: Alloderm

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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