Clinical trial NCT06753084: Keratinized Tissue Augmentation Using Porcine Collagen Matrix (Mucoderm®) Around Dental Implant
Official title: Keratinized Tissue Augmentation Using Porcine Collagen Matrix (Mucoderm®) Around Dental Implant: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Keratinized Mucosa
Keywords: keratinized tissue width , porcine collagen matrix
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
Collaborators: name: Misr University for Science and Technology
First posted: 2024-12-31
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Keratinized mucosa width
timeFrame: 1 month , 3 month , 6 months follow up
measure: keratinized tissue thickness
timeFrame: 1 month , 3 month , 6 months follow up
Secondary outcomes:
measure: probing depth for adjacent teeth
timeFrame: 6 months
measure: bleeding on probingn
timeFrame: 1 month , 3 month , 6 months follow up
measure: crestal bone loss around dental implant
timeFrame: 1 month , 3 month , 6 months follow up
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Misr university for science and technology
state: NJ
city: Giza
country: Egypt
facility: Misr university for science and technology
Study officials:
References: