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

Phase 1

Completed

• Conditions: Keratinized Mucosa

• Registration Number: NCT06753084
• Lead Sponsor: ahmed amer

Brief Summary

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

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

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-25
• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-21
• Last Update Submitted: 2024-12-21
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Keratinized mucosa width	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
keratinized tissue thickness	1 month , 3 month , 6 months follow up	measures the Keratinized tissue thickness using periodontal probe

Secondary Outcome Measures

Name	Time	Method
probing depth for adjacent teeth	6 months	probing depth for adjacent teeth
bleeding on probingn	1 month , 3 month , 6 months follow up	bleeding on probing for this patient is mesure using papillary bleeding index.
crestal bone loss around dental implant	1 month , 3 month , 6 months follow up	measuring crestal bone loss around implant using CBCT and periapical xray

Trial Locations

Locations (1)

Misr university for science and technology; 🇪🇬 Giza, Egypt