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Completed

NCT Number: NCT06753084

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

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 .

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Key information

Conditions

Keratinized Mucosa

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Misr university for science and technology, Giza, NJ, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alloderm

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

Primary outcomes

  1. Keratinized mucosa width

    Time frame: 1 month , 3 month , 6 months follow up

    before the operation reading , immediately after operation , 1 month follow up , 3 months follow up and 6 months follow up

    the reading will done using periodontal probe

  2. keratinized tissue thickness

    Time frame: 1 month , 3 month , 6 months follow up

    measures the Keratinized tissue thickness using periodontal probe

Secondary outcomes

  1. probing depth for adjacent teeth

    Time frame: 6 months

    probing depth for adjacent teeth

  2. bleeding on probingn

    Time frame: 1 month , 3 month , 6 months follow up

    bleeding on probing for this patient is mesure using papillary bleeding index.

  3. crestal bone loss around dental implant

    Time frame: 1 month , 3 month , 6 months follow up

    measuring crestal bone loss around implant using CBCT and periapical xray

Sponsors and collaborators

Lead sponsor

ahmed amer

Other

Collaborators

  • Misr University for Science and Technology

Registry information

Official study title

Keratinized Tissue Augmentation Using Porcine Collagen Matrix (Mucoderm®) Around Dental Implant: A Randomized Clinical Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 31, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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