| CTRI Number |
CTRI/2023/08/056587 [Registered on: 17/08/2023] Trial Registered Prospectively |
| Last Modified On: |
14/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of different materials for the treatment of lowering of gums |
|
Scientific Title of Study
|
Comparative evaluation of Sub-epithelial connective tissue graft and Xenogenic collagen membrane in the treatment of gingival recession: A Randomised controlled clinical trial. |
| 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. Shweta Ahlawat |
| Designation |
Academic junior resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Room no-5, Division of Periodontology, Department- Faculty of Dental Sciences, IMS BHU, Varanasi-221005
Varanasi UTTAR PRADESH 221005 India |
| Phone |
7976734778 |
| Fax |
|
| Email |
shweta.ahlawat2@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Sarita Parihar |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Room no-5, Division of Periodontology, Department- Faculty of Dental Sciences, IMS BHU, Varanasi
Varanasi UTTAR PRADESH 221005 India |
| Phone |
8004925677 |
| Fax |
|
| Email |
drsarita6@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Shweta Ahlawat |
| Designation |
Academic junior resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Room no-5, Division of Periodontology, Department- Faculty of Dental Sciences, IMS BHU, Varanasi
Varanasi UTTAR PRADESH 221005 India |
| Phone |
7976734778 |
| Fax |
|
| Email |
shweta.ahlawat2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Sciences, IMS BHU, Varanasi |
|
|
Primary Sponsor
|
| Name |
Shweta Ahlawat |
| Address |
Unit of Periodontology, Faculty of Dental Sciences, IMS BHU, Varanasi-221005 |
| Type of Sponsor |
Other [Self Sponsoring] |
|
|
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 Shweta Ahlawat |
Faculty of Dental Sciences, Institute of medical sciences, Banaras Hindu University |
Room no-5, Division of Periodontology, Department-Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi Varanasi UTTAR PRADESH |
7976734778
shweta.ahlawat2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Teeth with gingival recession |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Evaluation of sub-epithelial connective tissue graft in the treatment of gingival recession |
Graft is obtained from palate. Dimensional changes are observed before the surgical procedure, after 3 months, and at 6 months. |
| Intervention |
Xenogenic collagen membrane in the treatment of gingival recession |
Dimensional changes are observed before the surgical procedure, after 3 months, and at 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy subjects with class I (Marginal tissue recession, which does not extend to the mucogingival junction (MGJ)) /II (Marginal tissue recession extending to or beyond mucogingival junction (MGJ) with no radiographic sign of bone loss and requiring surgical intervention for root coverage)
2. Probing pocket depth <3mm
3. No prior history of any surgical procedures on the site to be treated.
4. Presence of detectable CEJ.
5. Not using tobacco in any form.
6. Systemically healthy subjects with no contraindication to periodontal surgery.
7. Able to achieve good oral hygiene.
8. Subjects who gave written consent.
9. Subjects who were available for follow up.
|
|
| ExclusionCriteria |
| Details |
1. Persistence of uncorrected gingival trauma from tooth brushing.
2. Presence of severe tooth malposition, rotation or clinically significant supraeruption.
3. Cervical or root caries, cervical abrasion, prosthetic crown and restorations involving cemento-enamel junction.
4. Pregnant and lactating mothers.
5. Hypersensitivity or allergy to the collagen based medical products. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Coverage of gingival recession in terms of both recession depth & width |
Baseline, & at 3 & 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gain in keratinised tissue width, Clinical attachment level, Probing Depth
and attached gingiva thickness
|
Baseline, & at 3 & 6 months |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
31/08/2023 |
| 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="8" Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
According to Glossary
of Periodontal terms (2001), gingival recession is defined as the apical
displacement of gingival margin in relation to cement enamel junction. One of
the common clinical findings in periodontal disease is gingival recession. The
attachment loss is because of the collapse of gingival tissue and destruction
of periodontal connective tissue.
Various factors like
plaque induced inflammation, trauma, high frenum attachment, traumatic
brushing, lack of alveolar bone due to lip and tongue piercing, dehiscence,
orthodontic movement, ageing, abnormal tooth position in the dental arch,
iatrogenic factors, biologic width violation, smoking and tobacco chewing
habits have been suggested as etiological factors for gingival recession.
Gingival recession carries with itself not only aesthetic discrepancies but
also leads to exposure of root surface. The exposure of root surface is
associated with root hypersensitivity, difficulties in achieving optimal plaque
control and development of root caries. Therefore, procedures involved in the
treatment of gingival recession improve aesthetics by restoring natural tissue
blending. These procedures also increase the thickness of soft tissues that
facilitate plaque control and prevent periodontal breakdown and development of
root caries.
As one of the greatest aesthetic
concerns associated with the periodontal tissues is gingival recession,
research is going on to find treatment modalities to address all the biological
and functional problems. This has led to the development of several new and
modified surgical techniques. There are various surgical techniques and their
modifications for the treatment of gingival recession. Surgical procedures used
in the treatment of recession defects may be categorised as coronally advanced
flap, pedicle soft tissue grafting procedures (lateral sliding flap, double
papilla flap), coronally repositioned flap and free soft tissue grafting
procedures such as epithelialized grafts or subepithelial connective tissue
grafts.
SCTG helps in improved
long-term stability of complete root coverage (CRC) and it is accepted as the
gold standard in the treatment of gingival recessions. However, the requirement
of a second surgical site, limited amount of graft, rather low patient
tolerance and high complication rates in donor area are the major disadvantages
of SCTG. To reduce these disadvantages, barrier membrane, platelet-rich plasma,
platelet-rich fibrin, enamel matrix derivatives and graft substitute materials
have been used as an alternative to SCTG.
Periodontal
connective tissue predominantly consists of type 1 collagen fibres. Thus,
researchers developed many different kinds of collagen membranes for using as
grafting material using type 1 collagen as the major component. The additional
benefits of collagen material is hemostasis, chemotaxis for periodontal
fibroblasts, gingival fibroblasts, weak immunogenicity, easy manipulation and
ability to augment tissue thickness. Hence, collagen appears as an ideal choice
for use in guided tissue regeneration procedures and soft tissue grafting.
Recently, a new
xenogeneic collagen membrane (XCM) has been used in periodontal regenerative
procedures. It is highly biocompatible and contains purified intact collagen. It
has high mechanical strength. Also, it is soft and very drapable, yet
repositionable for precise adjustment and placement. It has an additional
advantage that it does not stick to instruments. Hence, XCM seems to be a
promising soft tissue graft substitute. It is not only less invasive and time saving
but also provides unlimited off-the-shelf supply of graft material and has been
cleared by U.S. Food and Drug Administration (FDA). Very few studies have been
done on the use of XCM for root coverage procedures. Hence, the present
research work aims to evaluate and compare SCTG and XCM in the treatment of
gingival recession using the modern alteration of coronally advanced tunnel
technique. In our study, we aim to
evaluate and compare the clinical efficacy of XCM to SCTG in the treatment of
Miller’s class I / class II gingival recession.
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