| CTRI Number |
CTRI/2020/02/023387 [Registered on: 17/02/2020] Trial Registered Prospectively |
| Last Modified On: |
14/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparision Between Healing Of Dimentionally Altered Autograft With An Allograft For Treatment Of Gum Recessions |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF HEALING EVENTS AFTER USING
MODIFIED CONNECTIVE TISSUE GRAFT TECHNIQUE AND COLLAGEN
MEMBRANE IN THE TREATMENT OF ISOLATED GINGIVAL
RECESSIONS- A CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ALLURI SRI NEHA RAJU |
| Designation |
POST GRADUATE |
| Affiliation |
LENORA INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF PERIODONTOLOGY ROOM NO 5
LENORA INSTITUTE OF DENTAL SCIENCES
NH-16,Rajanagaram-533294
DEPARTMENT OF PERIODONTOLOGY ROOM NO 5
LENORA INSTITUTE OF DENTAL SCIENCES
NH-16,Rajanagaram-533294
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
8500757898 |
| Fax |
|
| Email |
dr.nehaalluri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupasree G |
| Designation |
PROFESSOR |
| Affiliation |
LENORA INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF PERIODONTOLOGY ROOM NO 5
LENORA INSTITUTE OF DENTAL SCIENCES
NH-16,Rajanagaram-533294
DEPARTMENT OF PERIODONTOLOGY ROOM NO 5
LENORA INSTITUTE OF DENTAL SCIENCES
NH-16,Rajanagaram-533294
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
9866098433 |
| Fax |
|
| Email |
drrupasree14@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupasree G |
| Designation |
PROFESSOR |
| Affiliation |
LENORA INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF PERIODONTOLOGY ROOM NO 5
LENORA INSTITUTE OF DENTAL SCIENCES
NH-16,Rajanagaram-533294
DEPARTMENT OF PERIODONTOLOGY ROOM NO 5
LENORA INSTITUTE OF DENTAL SCIENCES
NH-16,Rajanagaram-533294
East Godavari
ANDHRA PRADESH
533294
India |
| Phone |
9866098433 |
| Fax |
|
| Email |
drrupasree14@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| LENORA INSTITUTE OF DENTAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
ALLURI SRI NEHA RAJU |
| Address |
DEPARTMENT OF PERIODONTOLOGY ROOM NO 5
LENORA INSTITUTE OF DENTAL SCIENCES RAJANAGARAM |
| 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 |
| DrALLURI SRI NEHA RAJU |
LENORA INSTITUTE OF DENTAL SCIENCES |
DEPARTMENT OF PERIODONTOLOGY ROOM NO 5
LENORA INSTITUTE OF DENTAL SCIENCES
NH-16,Rajanagaram-533294
East Godavari
ANDHRA PRADESH |
8500757898
dr.nehaalluri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ISOLATED GINGIVAL RECESSIONS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Collagen Membrane BIOGIDE |
Collagen Membrane BIOGIDE With Coronally Advanced Flap In The Treatment Of Isolated Gingival Recessions |
| Intervention |
Sub Epithelial Connective Tissue Graft |
Dimentionally altered SCTG with coronally advanced flap for treatment of isolated gingival recessions |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with mean age group of 20-50yrs.
2. Patients having one Pair of isolated Gingival Recessions.
3. Patients with Millers class I or class II Buccal Gingival Recessions.
4. Patients who had defects in maxillary anteriors and premolars and who
have ability to maintain good oral hygiene.
5. Patients willing to comply with all the study-related procedures, and
those available for follow-up.
6. The plaque index following periodontal therapy has to be <1. |
|
| ExclusionCriteria |
| Details |
1. Patients who had history of prolonged use of antibiotics.
2. Patients who had periodontal therapy in the preceding 6 months.
3. Pregnant and lactating women.
4. Patients who use tobacco in any form.
5. Patients who had history of systemic diseases.
6. Patients Unwilling for treatment.
7. Gingival recession associated with severe cervical abrasion. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Complete Root Coverage With Faster Healing Without Post Operative Pain |
Every Day In The 1st Week
Once In 6th, 12th And 24th Week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Stablility Of Root Coverage
Diffrence In Healing Index And Pain Perception In The First Week
Difference In Clinical Parameters I.E. Probing Depth,
Clinical Attachment Level, Gingival Thickness, Keratinized Tissue
Height Between Modified Connective Tissue Graft And Collagen
Membrane.
|
Every Day In The 1st Week
Once In 6th, 12th And 24th Week
|
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
AIM:
To evaluate the efficacy of healing and pain perception after using
Modified Connective tissue graft and Collagen membrane in isolated Millers
class I and class II Gingival Recessions. OBJECTIVES OF THE STUDY:
1. Evaluating the efficacy of Modified Connective Tissue Graft and
Collagen Membrane in treating gingival recession.
2. Evaluating the healing and pain perception with Modified Connective
Tissue Graft and Collagen Membrane in treating Gingival Recession.
3. Estimating the difference in clinical parameters i.e. Probing Depth,
Clinical Attachment Level, Gingival Thickness, Keratinized Tissue
Height between Modified Connective Tissue Graft and Collagen
Membrane. NEED FOR THE STUDY : So far there is only one randomised control trail analysing the effect of
Modified Connective Tissue Graft dimensions on the predictability of root
coverage. Literature stated that Sub epithelial Connective Tissue Graft is gold
standard procedure although Guided Tissue Regeneration has also shown
equal results in predictability of root coverage.
This study is the first of its kind to compare and analyse the healing and
predictability of dimensionally altered Modified Connective Tissue Graft
(MCTG) with Guided Tissue Regeneration. |