38 Clinical Trials for Various Conditions
The primary objective of this randomized clinical trial is to compare the mean root coverage achieved with Coronally Advanced Flap (CAF) + Connective Tissue Graft (CTG) (control) to Gingival Pedicle Split Thickness flap (GPST) + CTG (test) for the treatment of isolated gingival recession defects in mandibular incisors. The secondary objectives are to compare the percentage of complete root coverage and keratinized tissue gain between the two techniques.
The goal of this randomized clinical trial is to compare whether soft tissue augmentation placed in the donor site following a gum graft harvesting leads to volumetric changes compared to non-augmented sites in the palate. The main questions it aims to answer are: * Are there tissue thickness changes between the two groups (control group and augmentation group)? * Are there volumetric changes in the donor site (palate) between the two groups in the short and long term? Participants will receive a gum graft and then based on what group they were randomly assigned, they will receive either a collagen matrix where the gum graft was taken (on the palate) or nothing will be placed. Researchers will compare non-augmented sites with augmented sites to see if there is a change in tissue thickness and volume.
The goal of this clinical trial is to compare different de-epithelialization methods in patients undergoing soft tissue augmentation surgery. The main questions it aims to answer are: • Which technique is superior for de-epithelialization in terms of remaining epithelium, wound healing of the donor site, and clinical outcomes?
24 patients will be treated with a coronally positioned tunnel with AlloDerm RTM with or without the addition of Enamel Matrix Derivative to compare the baseline and 6-month changes in recession defect coverage, clinical attachment levels, amount of keratinized tissue width, and soft tissue thickness.
The study will consist of a randomized controlled clinical study trial comparing the results of coronally positioned flap with AlloDerm GBR plus bovine derived xenograft versus coronally positioned tunnel with AlloDerm GBR plus bovine derived xenograft in approximately 30 patients (15 per group). All materials used in the study are FDA approved.
The study aims to test the non-inferiority of an Allogenic Dermal Matrix with Platelet-Rich Fibrin for treatment of gingival recessions in comparison to the Connective Tissue Graft.
Prospective, randomized, within subjects-controlled design
This study compares the efficacy of root coverage achieved by the Pinhole Surgical Technique (PST) technique and the Connective Tissue Graft (CTG) technique in the treatment of Miller class I and II gingival recession defects. All patients will receive PST in one quadrant and CTG in another quadrant. The hypothesis being tested is: Pinhole Surgical Technique outcomes are not inferior to those of the Connective Tissue Graft surgical technique.
This study will compare two incision designs to allow for coronal gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix (ADM) graft around teeth with gingival recession and a lack of adequate keratinized gingiva. The SAMRI technique described is a novel technique involving a simplified incision and suturing technique and to the investigators' knowledge, this is the first study that seeks to compare this technique to other techniques for differences in clinical outcomes (percentage root coverage, resultant tissue thickness, and width of keratinized tissue) and patient-centered outcomes (post-operative pain, swelling, changes in daily activities, and patient-assessed esthetics) in a controlled study.
Rationale: Treatment of gingival recession defects requires coronal advancement of the gingival margin due to patient esthetic demand, tooth sensitivity and improvement of tooth prognosis, which can be accomplished either through a flap procedure or through a tunnel. It will be desirable to determine the efficacy of Vestibular Incision Subperiosteal Tunnel Access (VISTA) to Coronally Advanced Flap (CAF) procedure and intrasulcular tunneling. Another aspect of the study is to determine whether autologous concentrate of platelets and leukocytes (leukocyte-platelet-rich fibrin; L-PRF) has equivalent efficacy to connective tissue autologous graft harvested from the palate. The overall objective of this study is to evaluate the effectiveness of therapeutic modalities for the treatment of multiple gingival recession defects. The study is designed as a prospective, randomized controlled clinical trial. Four groups will be compared: Group 1: Coronally Advanced Flap (CAF) Group 2: VISTA Group 3: Intrasulcular tunneling (IST) Group 4: VISTA + L-PRF Each of the groups will be treated without any graft material in order to examine the efficacy of coronal advancement and periodontal root coverage without the confounding variable of graft material. These techniques don't require any additional graft if there is adequate amount of keratinized gingiva The study population will be patients who present to Advanced Graduate Program in Periodontology at the University of Southern California, USA, and are deemed to require treatment of multiple gingival recession defects. A total sample of 100 participants (23 participants per group) will provide a two sided test of means with 80% power at alpha of 0.05. The calculation was carried out using PASS Version 12 (Hintze, J. (2014). NCSS, LLC. Kaysville, Utah.) The study duration will be 1 year. Follow-up visits after the surgery will occur after 3 days , 7 days and at weeks 3, 6, 12, 24, 36 and 52. These follow up visits consistent with standard of care follow up for gingival recession treatment and there will be no additional costs to the participant. The Primary Outcome variable is complete root coverage; the Secondary Outcome Variables are clinical attachment level (CAL) gain, changes in gingival thickness and volume and the Tertiary Outcomes are aesthetic outcomes, postoperative pain and Patient satisfaction survey
Can a fetal bovine derived membrane serve as an alternative to autogenous tissue for dental root coverage procedures.
The purpose of this study is to evaluate CelTx as an alternative to tissue from the palate in the treatment of subjects with Miller Class I or II recession defects who desire root coverage. It is anticipated that this study will demonstrate that CelTx is a safe alternative to palatal tissue and demonstrate potential to enhance oral soft tissue regeneration and wound healing.
Study Purpose and Objectives: This study will utilize calcium hydroxylapatite (CaHA) to treat recession and hypersensitivity of the gums. The objectives of the study are: 1. to study the quality and quantity of changes in attached gums resulting from Radiesse(+) injections in the gingival tissue; 2. to determine the efficacy of Radiesse(+) in the reduction of tooth hypersensitivy caused by exposed roots relating to gingival recession; 3. to determine the efficacy of Radiesse(+) in the treatment of mild and moderate gingival recession.
This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing root coverage for gingival recession will be enrolled.
The goal of this clinical trial is to evaluate the dimensional changes in the short and long-term in patients with thin gum tissues who have gum grafts placed on either denuded bone or gum grafts placed on a bone with some tissues remaining. The main question this study aims to answer is: - Does the placement of free-epithelized gingival grafts (gum grafts) on full thickness bed preparation (having all of the tissue removed from the bone) lead to similar clinical, digital, and patient-related outcomes and measurements over a period of 12 months versus split thickness bed preparation (where a small layer of tissue is left over the bone) in patients with thin gum tissue phenotypes (gum tissue is generally less than 1.5 millimeters) who are in need of soft tissue augmentation procedures? Participants will be asked to attend 8 visits, which include: (i) screening visit, (ii) prophylaxis visit, (iii) random assignment to Group A or Group B along with surgery and digital data collection, (iv) 2-week post-operative visit, (v) 6-week post-operative visit, (vi) 3-month follow-up visit, (vii) 6-month follow-up visit, (viii) 12-month follow-up visit. Also, Group A will have a free epithelialized gingival/mucosal graft (gum graft) placed on full thickness periosteal bed preparation where all of the tissue was removed (test group). Group B will have a free epithelialized gingival/mucosal graft (gum graft) on split thickness periosteal bed preparation where only a portion of the tissue was removed (control group). Researchers will compare Group A and Group B to see if there is a difference in clinical, digital, and patient-related outcomes and measurements over a period of 12 months.
To correct gum recession, patient's own tissue from the roof of the mouth is harvested and placed where there is root exposed. This is considered gold standard of treatment. Sometimes patient don't want to have second surgical site in their mouth and at the same time do not want to use alternative tissue from human or animal donor. Using patients' blood and preparing it as a membrane is the next best thing to correct gum recession.
This study is to compare the two techniques to achieve change in the tissue quality at areas of lack of Keratinized Tissue (KT) using soft tissue grafting with autogenous graft material (Free Gingival Graft)(FGG) vs Strip gingival graft with acellular dermal matrix (ADM) (SGG+ADM).
This is an assessor-blinded split-mouth randomized clinical study to compare root coverage and gingival tissue thickness following two different surgical procedures for non-autologous grafting: the pinhole surgical technique (PST) and tunnel technique.
The present randomized clinical trial is aimed at evaluating the efficacy of recombinant human platelet-derived growth factor in combination with collagen matrix for the treatment of multiple adjacent gingival recessions
This double blind, randomized, split mouth study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for the treatment of Miller Class I or II recession defects at 6 months post treatment.
This randomized clinical comparative study will evaluate the postoperative pain following the FGG graft harvest procedure technique covered by four different methods for coverage of the palatal donor site.
Platelet-rich fibrin (PRF) and Autologous Fibrin Glue (AFG) are fibrin preparation derived from human blood samples and are used in regenerative dentistry. Aim: The aim of this study is to evaluate the level of root coverage using PRF (+) AFG with a coronally advanced flap (CAF) or PRF only with a CAF compared to a sub-epithelial connective tissue graft (CTG) with a CAF for treating Class 1 and 2 gingival recession defects. Additionally, to evaluate the level of keratinized tissue tissue thickness and width using PRF (+) AFG with a CAF or PRF only with a CAF compared to CTG with CAF for Class 1 and 2 gingival recession defects. Method: 48 patients with recession defects will be randomly divided into three different treatment groups. Treatment Group A (n=16) will consist of patients treated with PRF (+) AFG with a CAF, Group B (n=16) will consist of patients treated with PRF only with a CAF and Group C (n=16) will consits of patients treated with CTG with CAF as a control. Clinical measurements will be assessed at baseline and at 1 month and 6 months after the surgery. The clinical measurements that will be recorded, include probing depth, clinical attachment level, and gingval recession parameters. The gingival recession parameters include recession width, depth and thickness.
The primary purpose of this protocol is to isolate, investigate and compare the regenerative and differentiation potential of mesenchymal stem cells (MSC's) in the gingival (gum) tissue harvested from two different locations from the roof of the mouth (palate), that is from the front part(premolar)and back part(molar). MSC's are known for their capacity to form different kinds of hard and soft tissue including bone, fibers for periodontal ligaments, cementum and dentin, thus this study can help in optimizing their clinical application and transplantation approaches in tissue regeneration.
This study will compare two incision designs to allow for coronal gingival/mucosal flap advancement and tissue augmentation with acellular dermal matrix (ADM) graft around teeth with gingival recession and a lack of adequate keratinized gingiva. To the investigators knowledge, these two techniques have not been compared for differences in clinical (amount of root coverage, tissue thickness, and esthetics) and patient-centered outcomes (pain, swelling, change in daily activities) in a controlled study.
A single center, prospective clinical trial is planned to investigate the effect of different emergence angles of implant restorations on peri-implant soft tissue recession and implant marginal bone loss. The primary outcome is to systematically evaluate the association of implant-, peri-implant tissue-, and restoration-related factors with facial mucosal level changes.
The purpose of this prospective, double-blinded, randomized, split-mouth study is to compare the effectiveness of a porcine collagen matrix (CM) and coronally advanced flap (CAF) with or without the addition of enamel matrix derivative (EMD) in the treatment of Miller Class I, II, or predictable class III recession defects. One defect will receive CM + CAF + EMD (Experimental), while the other will receive CM + CAF (Control) alone. The treatment of 60 similarly sized Miller class I, II, or predictable class III recession defects on single-rooted teeth in 30 subjects using CM + CAF + EMD or CM + CAF alone will be evaluated. The subjects will be in good health, non-smokers, periodontally healthy with good oral hygiene and have no contraindications to periodontal surgery. Paired, similar sized defects on single-rooted teeth will be in the same subject and measure within 2mm of each other. One defect will be randomly assigned as the test group using CM + CAF + EMD, and the other as the control group using only CM + CAF. Clinical measurements will be made using a UNC-15 periodontal probe by calibrated, board certified periodontists and will include: probing depth (PD), clinical attachment level (CAL), vertical recession (RD), and width of keratinized tissue (KT). Percent root coverage (%RC) will be calculated. The measurements will be used to evaluate surgical outcome. Surgical outcome will also be assessed using stone models. All measurements will be taken at baseline (on the day of the surgery) and 3 and 6 months post-surgery for comparison.
To study and compare a thick vs thin acellular dermal matrix for root coverage using the coronally positioned tunnel technique.
Gingival recession is a common defect among the American population. It is also a major cause for root decay, hypersensitivity, contributes to tooth mobility and low self-esteem. Acellular dermal matrix, a human-derived grafting material has been put on the market for the treatment of gingival recession. Treating gingival recession with this material has been a validated treatment option for years. However, treatment outcomes in two patient populations, namely those with thin biotypes and those with thick biotypes, has not been investigated. This study will observe the primary treatment outcomes in the two patient groups at 5 time points - 3 months, 6 months and 12 months post-surgery to observe short term outcomes; additional 24 months and 48 months post-surgery to observe long term outcomes.
Root coverage with acellular dermal matrix using the coronally positioned tunnel technique comparing two different donor materials
Is PriMatrix wound dressing capable of regenerating gum tissue inside the mouth?