| CTRI Number |
CTRI/2024/06/068753 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of the wound protection
ability of Absorbable Collagen Wound Dressings and its impact on wound
healing and post-operative pain with sutures. |
|
Scientific Title of Study
|
A prospective, randomized controlled clinical trial comparing the wound protection
ability of Absorbable Collagen Wound Dressings and its impact on palatal wound
healing and post-operative pain. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nihal Devkar |
| Designation |
Professor |
| Affiliation |
Sinhgad Dental College and Hospital, Pune |
| Address |
Department 4, -2 floor, Sinhgad Dental College and Hospital, S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra
Department 4, -2 floor, Sinhgad Dental College and HospitalS. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra
Pune
MAHARASHTRA
411041
India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nihal Devkar |
| Designation |
Professor |
| Affiliation |
Sinhgad Dental College and Hospital, Pune |
| Address |
Department 4, -2 floor, Sinhgad Dental College and Hospital, S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra
Department 4, -2 floor, Sinhgad Dental College and Hospital, S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra
Pune
MAHARASHTRA
411041
India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nihal Devkar |
| Designation |
Professor |
| Affiliation |
Sinhgad Dental College and Hospital, Pune |
| Address |
Department 4, -2 floor, Sinhgad Dental College and Hospital, S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra
Department 4, -2 floor, Sinhgad Dental College and Hospital, S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra
Pune
MAHARASHTRA
411041
India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sinhgad Dental College and Hospital, Pune |
|
|
Primary Sponsor
|
| Name |
Dr Snehal Pudke |
| Address |
Department 4, -2 floor, Sinhgad Dental College and Hospital, S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Snehal Pudke |
Sinhgad Dental College And Hospital, Pune |
Department 4, -2 floor, Sinhgad Dental College And Hospital, S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra
Pune
MAHARASHTRA |
8600696344
snehalpudke07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sinhgad Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Palatal wound
healing and post-operative pain after a duration of 1 month. |
Wound protection
ability of Absorbable Collagen Wound Dressings and its impact on palatal wound
healing and post-operative pain after 1 month |
| Comparator Agent |
Palatal wound healing after a duration of 1 month |
Wound protection
ability of suturing and its impact on palatal wound
healing and post-operative pain after 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(1) Patients with age more than 18 years
(2) Patients who are systemically healthy with no systemic disease contraindicated to
dental surgery.
(3) Patients with palatal tissue thickness less than 2 mm evaluated with a University of North
Carolina (UNC) periodontal probe for bone sounding, placed perpendicular to the hard
palate before surgery.
(4) Patient having at least one site of natural dentition or dental implant that needed to
be treated by free gingival graft surgery or de-epithelialized gingival graft surgery for
one of the following indications including progressive recession, planned prosthodontics,
mucogingival deformity, or lack of keratinized gingiva. |
|
| ExclusionCriteria |
| Details |
Patients who smoke.
Patients with coagulation disorders (history of hemophilia, von Willebrand disease),
or currently subject to anticoagulant therapy.
Patients with altered healing patterns (i.e., type 2 diabetes mellitus). |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Absorbable
Collagen Wound Dressing with sutures on palatal wound healing after harvesting free gingival grafts (FGG) or De
epithelialized gingival graft (DGG) utilizing a healing index. |
1 week, 2week and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Absorbable
Collagen Wound Dressing with sutures on
postoperative pain after harvesting free gingival grafts (FGG) or De
epithelialized gingival graft (DGG) utilizing a Visual Analogue
Scale (VAS) questionnaire. |
1 week, 2 weeks & 1 month |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
During the last decades, the field of periodontology has been vastly influenced by the
esthetic trend with various surgical procedures proposed in the literature for treating
gingival recession (GR). In 1984, Hall concluded that the combination of predisposing
factors such as inadequate attached gingiva, high frenum attachment, mal-positioned teeth
and osseous dehiscence and precipitating factors such as vigorous tooth brushing,
laceration, recurrent inflammation and other iatrogenic factors contributes to the
pathogenesis of gingival recession. Evidence shows that with minimal amount of
keratinized and attached gingiva, periodontal health can be maintained. However, due
to the unpredictability of patient habits or other iatrogenic factors, periodontal plastic
surgery may still be required for natural teeth or dental implants in some circumstances
when risk factors are present.
Soft Tissue Grafting in Periodontology
Free gingival grafts (FGG) and De-epithelialized gingival graft (DGG) have been found
to be the most commonly grafts used in periodontal plastic surgeries to correct
mucogingival defects in morphology, position and/or amount of soft tissue and
underlying bone support for teeth and dental implants. The free gingival graft was first
described by Bjorn in 1963. Sullivan and Atkins in 1968 then explored the feasibility
and healing of the free gingival graft. The predictability and long-term stability of
the surgical outcome for free gingival graft has been well established. Similarly
coronally advanced flap (CAF) + SCTG is considered the ‘gold standard’ for the
treatment of Miller Class I and II GR. however, these surgical procedures require
autogenous graft harvesting. Harvesting the donor graft from the palate can cause longer
chair time, higher possibility of healing morbidity, and intra- and/or postoperative
discomfort, which can lower patient acceptance.
Postoperative management of donor site
The surgical technique of free gingival grafting requires harvesting of soft tissue from
the palatal donor site and transplantation to the intraoral recipient site. Post-surgical
complications and atypical healing processes have been described in the literature. Postoperative pain, swelling, excessive hemorrhage, infection and graft shrinkage are the
most common complications, additionally, bone exposure, recurrent herpetic lesions,
mucoceles and arteriovenous shunts have been reported. In order to reduce the
morbidity events associated with mucogingival surgery, there are several ways to manage
the donor site after soft tissue harvesting. Use of analgesics has become a standard of
care after surgery, and adjuncts such as surgical dressings, collagen matrices, different
suturing methods and plastic palatal protective stents can also be used to improve patient
comfort and reduce bleeding of donor sites. In a split mouth prospective randomized
clinical trial, Alec Yen et al. in 2007 showed that platelet concentration may accelerate
wound healing and regeneration of soft tissue, however, there were no statistical
differences in terms of the occurrences of complications or post-operative pain.
Hemostatic agents
Various hemostatic agents have been employed to manage post-operative bleeding at the
donor site. Currently the interest is focused upon absorbable synthetic collagen,
absorbable gelatin sponge, and oxidized regenerated cellulose. Side effects of application
the used of hemostatic agents include foreign body reactions or retarded healing of the
wound. It has been demonstrated that Absorbable Collagen sponge wound dressing
is bactericidal against broad range of gram-positive and gram- negative organisms
including antibiotic resistant bacteria (MRSA, VRE, PRSP and MRSE) When applied
in periodontal surgery, Pollack and Bouwsma found that the bactericidal activity is non
specific and effective against several periodontal pathogens. Seven to ten days after
application, the material degraded and released carboxylic acid moieties, which lower
the pH. The low pH of the carboxylic acid helped local hemostatic action and then
activated the platelets to form a temporary plug. The low pH of carboxylic acid groups
also created an acidic environment in which most of the bacteria were unable to survive. |