CompletedPhase 1

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

Egypt22 participantsStarted 2023-11-01

Plain-language 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 .

Who can participate

Age range

20 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Keratinized mucosa width

Timeframe: 1 month , 3 month , 6 months follow up

keratinized tissue thickness

Timeframe: 1 month , 3 month , 6 months follow up

Trial details

NCT IDNCT06753084

Sponsorahmed amer

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-01

View on ClinicalTrials.gov More Keratinized Mucosa trials